Data / Medical devices / United States / Medtronic, Inc.
Medtronic, Inc.: FDA-registered device maker in Mounds View, MN, United States, 99 510(k) clearances and 27 PMA approvals
Medtronic, Inc. is registered with the FDA (registration 2182208) in Mounds View, MN, United States. It lists 46 device types. The FDA files 99 510(k) clearances and 27 PMA approvals under its listings, the newest dated December 19, 2025. 95 recall events name it as the recalling firm (6 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2182208
- Address
- 8200 Coral Sea Street NE, Mounds View, MN, United States, 55112
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 2, 1992
- Registered through
- 2027
- Brand names listed
- 10-Lead 2ACHC, AORTIC CUFF, ATAKR, ATRIAL LIFT SYSTEM, AURORA EV-ICD MRI SURESCAN SW041, Accessory, Accessory Port ATS Medical Thoracic Port System, AccuRhythm AI (Zelda AI) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2025 | K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 17, 2025 | K243892 | Affera Integrated Mapping System | DQK | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 5, 2024 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | DQK | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 1, 2024 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | DQK | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 28, 2024 | K240693 | LINQ II Insertable Cardiac Monitor (ICM) | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 8, 2024 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | DQK | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 17, 2023 | K233691 | FlexCath Cross Transseptal Solution | DYB | Substantially Equivalent | Acutus Medical, Inc. | accessdata.fda.gov |
| December 6, 2023 | K233562 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 2, 2023 | K233397 | Cosine-10TM Diagnostic Catheter | DRF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 31, 2023 | K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 31, 2023 | K232321 | FlexCath Contour Steerable Sheath | DRA | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 26, 2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 5, 2023 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 25, 2022 | K221962 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 8, 2022 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Substantially Equivalent | Acutus Medical, Inc. | accessdata.fda.gov |
| July 22, 2021 | K212008 | Reveal LINQ Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 12, 2021 | K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | DSA | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 11, 2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 28, 2021 | K211304 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 6, 2021 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Substantially Equivalent | Acutus Medical, Inc. | accessdata.fda.gov |
| November 13, 2020 | K202620 | FlexCath Advance Steerable Sheath and Dilator | DRA | Substantially Equivalent | Medtronic Cryocath, LP | accessdata.fda.gov |
| August 3, 2020 | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 3, 2020 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 13, 2020 | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 8, 2020 | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2020 | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 24, 2019 | K190574 | Patient Assistant Model PA97000 | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 30, 2019 | K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | DRF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| July 30, 2019 | K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | DRF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 30, 2019 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 15, 2019 | K183493 | SelectSite C304-HIS Deflectable Catheter System | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 26, 2018 | K183174 | FlexCath Advance Steerable Sheath and Dilator | DRA | Substantially Equivalent | Medtronic Cryocath, LP | accessdata.fda.gov |
| November 8, 2018 | K181918 | CardioInsight Cardiac Mapping System | DQK | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 21, 2018 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 7, 2018 | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 24, 2018 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 19, 2018 | K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 28, 2017 | K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | DTA | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 14, 2017 | K163460 | Reveal LINQ Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 2, 2017 | K163268 | FlexCath Select Steerable Shealth and Dilator | DYB | Substantially Equivalent | Medtronic Cryocath, LP | accessdata.fda.gov |
| November 15, 2016 | K162892 | Achieve Advance Mapping Catheter | DRF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 4, 2016 | K162440 | CardioInsight Cardiac Mapping System | DQK | Substantially Equivalent | Cardioinsight Technologies, Inc. | accessdata.fda.gov |
| October 12, 2016 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 26, 2016 | K160809 | Reveal LINQ | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 6, 2016 | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | DRF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 6, 2015 | K150614 | Reveal LINQ | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 2, 2015 | K150990 | ECVUE Mapping System | DQK | Substantially Equivalent | Cardioinsight Technologies, Inc. | accessdata.fda.gov |
| May 27, 2015 | K150117 | Medtronic Patient Asistant | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2015 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope | FTL | Substantially Equivalent | Medtronic Tyrx, Inc. | accessdata.fda.gov |
| March 11, 2015 | K143316 | Attain Hybrid Guide Wire | DQX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 18, 2015 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 19, 2014 | K140497 | ECVUE MAPPING SYSTEM | DQK | Substantially Equivalent | Cardioinsight Technologies, Inc. | accessdata.fda.gov |
| February 14, 2014 | K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 6, 2014 | K133701 | NUVANT MCT SYSTEM | QYX | Substantially Equivalent | Corventis, Inc. | accessdata.fda.gov |
| October 31, 2013 | K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 27, 2013 | K132030 | MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING | DYB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 20, 2013 | K130943 | AIGIS RX R PM/ AIGIS RX R ICD | FTL | Substantially Equivalent | Tyrx, Inc. | accessdata.fda.gov |
| April 9, 2013 | K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT | DQY | Substantially Equivalent | Medtronic, Ireland | accessdata.fda.gov |
| December 27, 2012 | K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | DRA | Substantially Equivalent | Medtronic Cryocath, LP | accessdata.fda.gov |
| June 8, 2011 | K110693 | PACEART OPTIMA SYSTEM SOFTWARE | KRE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 18, 2011 | K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE | DRF | Substantially Equivalent | Medtronic Ablation Frontiers, LLC | accessdata.fda.gov |
| September 9, 2010 | K101885 | MEDTRONIC C315 DELIVERY CATHETER | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 21, 2007 | K071655 | REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 21, 2007 | K071641 | REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) | DSI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 21, 2006 | K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | DQY | Substantially Equivalent | Medtronic, Ireland | accessdata.fda.gov |
| January 11, 2006 | K052459 | 6248VAL ADJUSTABLE VALVE | DTL | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| September 15, 2004 | K042194 | ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| July 17, 2003 | K031211 | ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| May 29, 2003 | K024278 | PACEART SYSTEM | DPS | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| October 9, 2002 | K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | DWS | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 28, 2001 | K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | DYG | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| February 23, 2000 | K000210 | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT | DTD | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular | accessdata.fda.gov |
| January 21, 2000 | K994331 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR | MXC | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| October 15, 1998 | K982220 | MODEL 2872 BIPOLAR LEAD ADAPTOR KIT | DTD | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Vascular | accessdata.fda.gov |
| August 5, 1998 | K981642 | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS | DRF | Substantially Equivalent | Medtronic Cardiorhythm | accessdata.fda.gov |
| May 26, 1998 | K973360 | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD | LDF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| July 25, 1997 | K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 | DYB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| July 14, 1997 | K971474 | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL | DTE | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| May 22, 1996 | K960446 | MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES | DSA | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 15, 1996 | K953185 | PLATINUM SERIES EP DIAGNOSTIC CATHETERS | DRF | Substantially Equivalent | Medtronic Cardiorhythm | accessdata.fda.gov |
| June 27, 1995 | K951313 | MEDAMICUS PERCUTANEOUS INTRODUCER | DYB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| May 10, 1995 | K951347 | MARINR SERIES EP DIAGNOSTI CATHETERS | DRF | Substantially Equivalent | Medtronic Cardiorhythm | accessdata.fda.gov |
| June 6, 1994 | K931794 | MARINR SERIES EP DIAGNOSTIC CATHETERS | DRF | Substantially Equivalent | Medtronic Cardiorhythm | accessdata.fda.gov |
| February 10, 1993 | K923915 | TORQR SERIES DIAGNOSTIC EP CATHETERS | DRF | Substantially Equivalent | Cardiorhythm | accessdata.fda.gov |
| October 19, 1992 | K923407 | MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES | LDF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 9, 1992 | K915563 | DIAGNOSTIC EP CATHETER | DRF | Substantially Equivalent | Arrhythmia Technologies, Inc. | accessdata.fda.gov |
| November 22, 1991 | K914460 | MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES | DRF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| June 18, 1991 | K911236 | MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS | DYB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| February 1, 1991 | K904575 | MODEL 5866-37M LEAD ADAPTOR KIT | DTD | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 23, 1990 | K900515 | MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) | DYB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| January 12, 1989 | K885101 | MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR | DSA | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| November 17, 1988 | K880738 | MODEL 2331T PATIENT PROGRAMMER | KRG | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 4, 1986 | K861368 | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | JOQ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| December 24, 1985 | K854559 | MEDTRONIC PERMANENT LEAD INTRODUCER | DYB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 16, 1985 | K851091 | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | JOQ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| September 27, 1984 | K843718 | PROGRAMMABLE STIMULATOR 5326 | JOQ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| January 30, 1984 | K833421 | PROGRAMMABLE STIMULATOR 2352 | JOQ | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| December 1, 1980 | K801284 | LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) | DTB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 22, 2025 | P240036 | OmniaSecure MRI SureScan Lead Model 3930M | NVY | 7 | October 23, 2026 | accessdata.fda.gov |
| October 24, 2024 | P240013 | Sphere-9 Catheter and Affera Ablation System | QZI | 32 | October 9, 2026 | accessdata.fda.gov |
| December 13, 2023 | P230017 | PulseSelect Pulsed Field Ablation (PFA) system | QZI | 11 | June 30, 2026 | accessdata.fda.gov |
| October 20, 2023 | P220012 | Aurora EV-ICD System | LWS | 75 | July 31, 2026 | accessdata.fda.gov |
| January 28, 2021 | P200028 | DiamondTemp Ablation System | OAE | 24 | October 10, 2025 | accessdata.fda.gov |
| April 6, 2016 | P150033 | MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM | PNJ | 225 | September 8, 2026 | accessdata.fda.gov |
| November 20, 2012 | P100047 | HEARTWARE VENTRICULAR ASSIST SYSTEM | DSQ | 227 | September 23, 2026 | accessdata.fda.gov |
| February 8, 2011 | P090013 | REVO MRI SURESCAN IPG AND PACING SYSTEM | LWP | 325 | June 5, 2025 | accessdata.fda.gov |
| December 17, 2010 | P100010 | ARCTIC FRONT CRYOCATHETER SYSTEM | OAE | 151 | September 25, 2026 | accessdata.fda.gov |
| April 7, 2009 | P080006 | MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD | OJX | 191 | June 24, 2026 | accessdata.fda.gov |
| August 3, 2005 | P030036 | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | NVN | 159 | October 16, 2026 | accessdata.fda.gov |
| April 17, 2003 | P020045 | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | LPB | 102 | April 23, 2026 | accessdata.fda.gov |
| June 26, 2002 | P010031 | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | NIK | 902 | October 5, 2026 | accessdata.fda.gov |
| August 28, 2001 | P010015 | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM | LWP | 574 | October 23, 2026 | accessdata.fda.gov |
| June 14, 2000 | P980050 | MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF | LWS | 142 | April 15, 2026 | accessdata.fda.gov |
| September 27, 1999 | P990001 | DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2 | NVZ | 119 | March 20, 2025 | accessdata.fda.gov |
| January 29, 1999 | P980035 | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE | NVZ | 822 | October 23, 2026 | accessdata.fda.gov |
| October 9, 1998 | P980016 | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | LWS | 933 | October 5, 2026 | accessdata.fda.gov |
| January 30, 1998 | P970012 | MEDTRONIC.KAPPA 400 SERIES PACEMAKERS | NVZ | 96 | March 20, 2025 | accessdata.fda.gov |
| March 29, 1996 | P930039 | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 | NVN | 267 | June 24, 2026 | accessdata.fda.gov |
| February 9, 1995 | P930029 | ATAKR(TM) RFCA SYSTEM | LPB | 66 | July 1, 2024 | accessdata.fda.gov |
| December 9, 1993 | P920015 | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | NVY | 294 | August 19, 2026 | accessdata.fda.gov |
| February 11, 1993 | P900061 | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | LWS | 170 | April 15, 2026 | accessdata.fda.gov |
| August 24, 1989 | P890003 | SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 | NVZ | 459 | July 31, 2026 | accessdata.fda.gov |
| July 29, 1986 | P850089 | CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS | NVN | 167 | April 15, 2026 | accessdata.fda.gov |
| July 29, 1986 | P830061 | STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING | NVN | 225 | June 24, 2026 | accessdata.fda.gov |
| November 16, 1982 | P820003 | VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR | LWP | 138 | March 20, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2026 | 100003 | Not yet classified | Open, Classified | CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable | Software problem has the potential for an inaccurate displayed longevity estimate. | accessdata.fda.gov |
| September 17, 2026 | 99970 | Not yet classified | Open, Classified | OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter deliver | Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty. | accessdata.fda.gov |
| March 11, 2026 | 98653 | Class II | Ongoing | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. | Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and | accessdata.fda.gov |
| October 29, 2025 | 97910 | Class II | Ongoing | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. | accessdata.fda.gov |
| June 18, 2025 | 97130 | Class II | Ongoing | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model N | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery. | accessdata.fda.gov |
| June 17, 2025 | 97125 | Class II | Ongoing | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara applicat | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there ar | accessdata.fda.gov |
| April 29, 2025 | 96722 | Class II | Ongoing | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment. | accessdata.fda.gov |
| July 11, 2024 | 95176 | Class II | Ongoing | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher. | accessdata.fda.gov |
| April 16, 2024 | 94674 | Class II | Ongoing | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. | accessdata.fda.gov |
| December 7, 2023 | 93663 | Class II | Ongoing | Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 | During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed. | accessdata.fda.gov |
| November 3, 2023 | 93411 | Class II | Ongoing | ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference. | accessdata.fda.gov |
| May 10, 2023 | 92328 | Class I | Ongoing | ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. | accessdata.fda.gov |
| June 22, 2022 | 90565 | Class I | Ongoing | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4 | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). | accessdata.fda.gov |
| April 20, 2022 | 90101 | Class II | Ongoing | The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflecta | The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. | accessdata.fda.gov |
| April 12, 2022 | 90085 | Class II | Ongoing | Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3 | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). | accessdata.fda.gov |
| January 18, 2022 | 89469 | Class II | Terminated | LINQ II Insertable Cardiac Monitor | Devices may lose functionality due to susceptibility to moisture ingress. | accessdata.fda.gov |
| November 19, 2021 | 89140 | Class II | Terminated | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System. | There have been reports of stent migration. | accessdata.fda.gov |
| November 8, 2021 | 89054 | Class II | Terminated | Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72 | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted." | accessdata.fda.gov |
| October 12, 2021 | 88907 | Class II | Ongoing | Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillat | The processing of collected episode data may fail due to a software error. | accessdata.fda.gov |
| September 9, 2021 | 88688 | Class II | Ongoing | C315-HIS Delivery Catheter | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. | accessdata.fda.gov |
| June 1, 2021 | 88175 | Class II | Ongoing | Medtronic Reveal LINQ LNQ11 / PA96000 | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians. | accessdata.fda.gov |
| May 14, 2021 | 88089 | Class II | Ongoing | Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. | accessdata.fda.gov |
| April 7, 2021 | 87769 | Class II | Terminated | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate b | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). | accessdata.fda.gov |
| April 6, 2021 | 87662 | Class II | Ongoing | Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. | accessdata.fda.gov |
| April 6, 2021 | 87654 | Class II | Ongoing | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). | There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT). | accessdata.fda.gov |
| February 3, 2021 | 87261 | Class I | Ongoing | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation | accessdata.fda.gov |
| November 15, 2020 | 86887 | Class II | Terminated | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE- | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. | accessdata.fda.gov |
| November 5, 2020 | 90429 | Class II | Ongoing | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) | Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements. | accessdata.fda.gov |
| July 13, 2020 | 93401 | Class II | Completed | Medtronic SynchroMed, Model A10 | The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm. | accessdata.fda.gov |
| June 4, 2020 | 85816 | Class II | Ongoing | CareLink SmartSync Device Manager, Model Number 24970A | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of auto | accessdata.fda.gov |
| January 30, 2020 | 84944 | Class II | Ongoing | Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. | Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information. | accessdata.fda.gov |
| October 3, 2019 | 84026 | Class II | Ongoing | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality. | accessdata.fda.gov |
| August 6, 2019 | 83547 | Class II | Terminated | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker. | Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant. | accessdata.fda.gov |
| March 4, 2019 | 82319 | Class III | Ongoing | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during ca | The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. | accessdata.fda.gov |
| January 17, 2019 | 81950 | Class II | Terminated | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, ge | accessdata.fda.gov |
| January 17, 2019 | 81949 | Class II | Terminated | MEDTRONIC CARELINK 2090 programmer | There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT). | accessdata.fda.gov |
| January 17, 2019 | 81945 | Class I | Ongoing | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality | accessdata.fda.gov |
| October 2, 2018 | 81300 | Class II | Ongoing | Medtronic CareLink 2090 Programmer | Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download. | accessdata.fda.gov |
| June 21, 2018 | 80433 | Class II | Terminated | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by prov | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP). | accessdata.fda.gov |
| June 21, 2018 | 80379 | Class II | Terminated | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyar | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no | accessdata.fda.gov |
| June 6, 2018 | 80267 | Class II | Terminated | Single Chamber Temporary External Pacemaker, Model 53401 | A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR). | accessdata.fda.gov |
| December 19, 2017 | 78888 | Class I | Terminated | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D | Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). | accessdata.fda.gov |
| July 14, 2017 | 77964 | Class II | Terminated | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a t | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports. | accessdata.fda.gov |
| April 12, 2017 | 76853 | Class II | Terminated | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan | An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices. | accessdata.fda.gov |
| December 9, 2016 | 75943 | Class II | Terminated | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fib | During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active. | accessdata.fda.gov |
| August 12, 2016 | 74923 | Class II | Terminated | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low h | accessdata.fda.gov |
| June 16, 2016 | 74424 | Class II | Terminated | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recor | This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage. | accessdata.fda.gov |
| May 26, 2016 | 74344 | Class II | Terminated | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for view | Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAle | accessdata.fda.gov |
| March 31, 2016 | 73780 | Class II | Terminated | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate impla | A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment | accessdata.fda.gov |
| February 23, 2016 | 73494 | Class II | Terminated | Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously. | Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 d | accessdata.fda.gov |
| November 9, 2015 | 72618 | Class II | Terminated | Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. | Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance. | accessdata.fda.gov |
| September 29, 2015 | 72115 | Class II | Terminated | Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins tha | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. | accessdata.fda.gov |
| September 15, 2015 | 72245 | Class II | Terminated | Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patie | Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional. | accessdata.fda.gov |
| September 1, 2015 | 72136 | Class II | Terminated | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. | An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. | accessdata.fda.gov |
| March 23, 2015 | 70846 | Class II | Terminated | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT81201 | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material. A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components | accessdata.fda.gov |
| March 17, 2015 | 70763 | Class II | Terminated | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by t | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping del | accessdata.fda.gov |
| February 23, 2015 | 70644 | Class I | Terminated | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies. | accessdata.fda.gov |
| April 29, 2014 | 68165 | Class II | Terminated | Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in | Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time. | accessdata.fda.gov |
| January 30, 2014 | 67400 | Class II | Terminated | Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arteri | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | accessdata.fda.gov |
| July 17, 2013 | 65831 | Class II | Terminated | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use i | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. | accessdata.fda.gov |
| July 8, 2013 | 65757 | Class II | Terminated | Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart. | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differ | accessdata.fda.gov |
| June 14, 2013 | 65732 | Class II | Terminated | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatri | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurolog | accessdata.fda.gov |
| June 12, 2013 | 65458 | Class II | Terminated | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therap | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package. | accessdata.fda.gov |
| June 7, 2013 | 65433 | Class II | Terminated | Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV | Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-insp | accessdata.fda.gov |
| March 13, 2013 | 64623 | Class II | Terminated | Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are int | Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. | accessdata.fda.gov |
| March 13, 2013 | 64620 | Class II | Terminated | Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta. | Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use. | accessdata.fda.gov |
| February 19, 2013 | 64417 | Class II | Terminated | Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69 | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. | accessdata.fda.gov |
| November 19, 2012 | 63769 | Class II | Terminated | Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493 | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. | accessdata.fda.gov |
| March 6, 2012 | 61356 | Not yet classified | Terminated | Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or | A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. | accessdata.fda.gov |
| December 14, 2011 | 60720 | Not yet classified | Terminated | Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile EO, Nonpyrogenic. Model number #'s : 67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 693 | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two | accessdata.fda.gov |
| August 29, 2011 | 60034 | Not yet classified | Terminated | Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoabla | Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributed with incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571, 25375, 25376, 25377, and 25381 of the Arctic Front Catheter Model Number 2AF282. Medtronic CryoCath is communicating this information to the F | accessdata.fda.gov |
| July 15, 2011 | 59477 | Not yet classified | Terminated | Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while | Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3FC12. There wave been reports of blood and saline solution leaking out of, and air ingress into the hemostatic valve. This includes reported instances of the introduction of air bubbles through the val | accessdata.fda.gov |
| April 4, 2011 | 58519 | Not yet classified | Terminated | Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product family, there are varyin | A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices) inappropriately trigger ERI/RRT in the Medtronic Dual Chamber Pacemakers: Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia. This is caused by a random lock-up of the measurement system hardware that may result in an incorrect battery voltage reading of zero | accessdata.fda.gov |
| October 25, 2010 | 57090 | Not yet classified | Terminated | Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., | Over--retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads. | accessdata.fda.gov |
| October 11, 2010 | 57098 | Not yet classified | Terminated | Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. | A subset of Model 5388 Dual-Chamber External Temporary Pulse Generators worldwide may be unable to power up or may power down unexpectedly. The issue presents itself in one of two ways. First, during startup, and prior to initiating patient therapy, the instrument may power down in 1 - 2 seconds. Second, the instrument may power up correctly, but power down | accessdata.fda.gov |
| June 11, 2010 | 56118 | Not yet classified | Terminated | Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart | Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue. | accessdata.fda.gov |
| May 5, 2010 | 55922 | Not yet classified | Terminated | Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. Medt | Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few | accessdata.fda.gov |
| March 8, 2010 | 55169 | Not yet classified | Terminated | Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting | The heparin assay controls may run longer than normal and in some cases, fail to give an acceptable result. | accessdata.fda.gov |
| February 25, 2010 | 54845 | Not yet classified | Terminated | Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in: Villalba, Puerto Rico. | Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect pro | accessdata.fda.gov |
| February 11, 2010 | 54686 | Not yet classified | Terminated | Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes | Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The | accessdata.fda.gov |
| September 9, 2009 | 53294 | Not yet classified | Terminated | Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA. | A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue d | accessdata.fda.gov |
| July 27, 2009 | 52853 | Not yet classified | Terminated | Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indi | Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant. | accessdata.fda.gov |
| May 18, 2009 | 52076 | Not yet classified | Terminated | Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303. | One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output. | accessdata.fda.gov |
| November 3, 2008 | 51135 | Not yet classified | Terminated | Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators. | Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts. | accessdata.fda.gov |
| August 27, 2008 | 49433 | Not yet classified | Terminated | Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | accessdata.fda.gov |
| July 25, 2008 | 50137 | Not yet classified | Terminated | Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. | Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not acce | accessdata.fda.gov |
| October 15, 2007 | 45403 | Not yet classified | Terminated | Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and def | Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel | accessdata.fda.gov |
| August 27, 2007 | 39422 | Not yet classified | Terminated | Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilitie | An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic I | accessdata.fda.gov |
| February 5, 2007 | 37587 | Not yet classified | Terminated | Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer | Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate. | accessdata.fda.gov |
| February 2, 2006 | 35141 | Not yet classified | Terminated | Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograp | The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists. | accessdata.fda.gov |
| November 29, 2005 | 34093 | Not yet classified | Terminated | Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 | An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due | accessdata.fda.gov |
| February 9, 2005 | 31142 | Not yet classified | Terminated | Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias | Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function. | accessdata.fda.gov |
| October 20, 2004 | 30369 | Not yet classified | Terminated | Medtronic CapSureFix Novus Lead Model 5076. | A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length. | accessdata.fda.gov |
| April 2, 2004 | 28798 | Not yet classified | Terminated | Medtronic Micro Jewel II Implantable Cardioverter Defibrillators, Model 7223Cx | Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices. | accessdata.fda.gov |
| November 25, 2002 | 25111 | Not yet classified | Terminated | Atakr II RF Power Generator, Models 4802 and 4803 | An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances. | accessdata.fda.gov |
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Updated October 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.