Data / Medical devices / United States / St. Jude Medical, Cardiology Division, Inc.
St. Jude Medical, Cardiology Division, Inc.: FDA-registered device maker in Plymouth, MN, United States, 126 510(k) clearances and 11 PMA approvals
St. Jude Medical, Cardiology Division, Inc. is registered with the FDA (registration 3005334138) in Plymouth, MN, United States. It lists 43 device types. The FDA files 126 510(k) clearances and 11 PMA approvals under its listings, the newest dated September 17, 2026. 25 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005334138
- Address
- 5050 Nathan Lane North, Plymouth, MN, United States, 55442
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 17, 1992
- Registered through
- 2027
- Brand names listed
- 'PEEL-AWY INTRO KIT, 2-port DVI splitter, 4 Outlet Reverse IEC Accessory Power Str, AMPLATZER Guidewires, ANGIO-SEAL HEMOSTATIC, AO USB Receiver, Abbott Medical Grounding Pad, Additional Monitor Stand Kit 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. Newest 100 of 126.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2026 | K261729 | EnSite X EP System | DQK | Substantially Equivalent | Abbott Medical | accessdata.fda.gov |
| July 15, 2026 | K262006 | EnSite X EP System | DQK | Substantially Equivalent | Abbott Medical | accessdata.fda.gov |
| April 20, 2026 | K260212 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 25, 2025 | K252013 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 4, 2025 | K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 30, 2025 | K251234 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 27, 2025 | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | GXI | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 20, 2025 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 13, 2024 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| August 9, 2024 | K242016 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 9, 2024 | K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | MTD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 13, 2024 | K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| August 10, 2023 | K231415 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 30, 2023 | K231588 | ViewFlex Eco Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 3, 2023 | K230934 | ViewFlex Eco Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| March 1, 2023 | K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 27, 2022 | K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 19, 2022 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 7, 2022 | K223077 | ViewFlex Xtra ICE Catheter | OBJ | Substantially Equivalent | Irvine Biomedical, A St. Jude Medical Company | accessdata.fda.gov |
| August 18, 2022 | K221213 | EnSite X EP System | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| January 21, 2022 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | GXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| November 11, 2021 | K213364 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| October 22, 2021 | K212061 | EnSite X EP System | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| March 11, 2021 | K210392 | WorkMate Claris System | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| November 25, 2020 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| October 21, 2020 | K201610 | IonicRF Generator | GXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 26, 2020 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 26, 2020 | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 17, 2019 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | DRF | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| February 28, 2019 | K183099 | QUANTIEN Measurement System | DQK | Substantially Equivalent | St. Jude Medical (Now Abbott Medical) | accessdata.fda.gov |
| December 12, 2018 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| October 19, 2018 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| April 23, 2018 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 23, 2018 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| March 28, 2018 | K180558 | PressureWire X | DXO | Substantially Equivalent | St. Jude Medical (Now Part of Abbott Medical) | accessdata.fda.gov |
| August 18, 2017 | K172182 | QUANTIEN Measurement System | DQK | Substantially Equivalent | St. Jude Medical (Now Part of the Abbott Medical) | accessdata.fda.gov |
| December 13, 2016 | K162643 | MediGuide Technology System | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 13, 2016 | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 13, 2016 | K160218 | AutoMark Module | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 13, 2016 | K160210 | EnSite Precision Cardiac Mapping System v2.0 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 15, 2016 | K161171 | PressureWire X Guidewire | DXO | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| October 22, 2015 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 15, 2015 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 15, 2015 | K151175 | ZONARE ZS3 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Zonare Medical Systems, Inc. | accessdata.fda.gov |
| April 1, 2015 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 13, 2014 | K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | DXO | Substantially Equivalent | St. Jude Medical Systems AB | accessdata.fda.gov |
| June 6, 2014 | K141050 | ENSITE VELOCITY SYSTEM | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 19, 2014 | K133853 | VIEWFLEX XTRA ICE CATHETER | OBJ | Substantially Equivalent | Irvine Biomedical, Inc., A St. Jude Medical Company | accessdata.fda.gov |
| March 11, 2014 | K140327 | ULTIMUM EV HEMOSTASIS INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 9, 2013 | K132073 | EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 3, 2013 | K130594 | ENSITE VELOCITY SYSTEM | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 28, 2013 | K123984 | QUANTIEN MEASUREMENT SYSTEM | DQK | Substantially Equivalent | Radi Medical Systems AB | accessdata.fda.gov |
| May 3, 2012 | K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER | MTD | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 2, 2012 | K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER | DXO | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| February 24, 2012 | K120301 | MEDIGUIDE TECHNOLOGY | DQK | Substantially Equivalent | St. Jude Medical, Mediguide Navigation Systems | accessdata.fda.gov |
| November 9, 2011 | K112688 | ENSITE VELOCITY SYSTEM V.3.0 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 21, 2011 | K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER | DRG | Substantially Equivalent | St. Jude Medical Systems AB | accessdata.fda.gov |
| September 20, 2011 | K111576 | NT 2000 LESIONING GENERATOR | GXD | Substantially Equivalent | Neuro Therm, Inc. | accessdata.fda.gov |
| June 9, 2011 | K111092 | ENGAGE/ENGAGE TR INTRODUCERS | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 10, 2011 | K110450 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| February 24, 2011 | K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | DXC | Substantially Equivalent | St. Jude Medical Systems AB | accessdata.fda.gov |
| January 26, 2011 | K110085 | VANTAGE VIEW SYSTEM | DXJ | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 18, 2010 | K102721 | LIVEWIRE ELECTOPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 15, 2010 | K101955 | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 7, 2010 | K101883 | 6F ENGAGE/ENGAGE TR INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 13, 2010 | K101623 | INQUIRY AFOCUSII DIAGNOSTIC CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| June 14, 2010 | K090608 | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) | GXI | Substantially Equivalent | Minta Medical Limited | accessdata.fda.gov |
| December 15, 2009 | K093583 | EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 4, 2009 | K093130 | ENGAGE TR INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 16, 2009 | K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | JOQ | Substantially Equivalent | Ep Medsystems | accessdata.fda.gov |
| October 9, 2009 | K092810 | EP-WORKMATE SYSTEM, VERSION 4.2 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 8, 2009 | K092575 | ENGAGE/ENGAGE TR | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 16, 2009 | K090955 | SMITH & NEPHEW RF CANNULATE | GXI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 22, 2009 | K083328 | ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 13, 2009 | K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 22, 2009 | K091137 | ULTIMUM/ENGAGE/ENGAGE TR | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| January 28, 2009 | K083528 | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 7, 2009 | K080179 | REFLEXION HD HIGH-DENSITY MAPPING CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 9, 2008 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 6, 2008 | K083083 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 22, 2007 | K072012 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 20, 2006 | K062251 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 3, 2006 | K061015 | FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 12, 2006 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 19, 2006 | K060757 | INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | Irvine Biomedical, Inc. | accessdata.fda.gov |
| February 24, 2006 | K053277 | CPS DIRECT SL OUTER CATHETER | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| January 23, 2006 | K052878 | NT-1000 | GXD | Substantially Equivalent | Neuro Therm, Inc. | accessdata.fda.gov |
| December 5, 2005 | K052644 | SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 4, 2004 | K042775 | INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | Irvine Biomedical, Inc. | accessdata.fda.gov |
| October 26, 2004 | K042375 | SMK, CX, CXE, RCN | GXI | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| February 25, 2004 | K033981 | SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 31, 2002 | K023447 | MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 1, 2002 | K022380 | LIVESIRE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 6, 2001 | K011387 | NEUROTHERM, MODEL JK4 | GXI | Substantially Equivalent | Eurolink, LLC | accessdata.fda.gov |
| June 6, 2001 | K010471 | AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 | DRF | Substantially Equivalent | Irvine Biomedical, Inc. | accessdata.fda.gov |
| January 3, 2001 | K003729 | ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 24, 2000 | K001346 | ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX | DYB | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| March 1, 2000 | K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | GXI | Substantially Equivalent | Mercury Medical | accessdata.fda.gov |
| March 1, 2000 | K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | P250022 | Volt PFA System | QZI | 10 | October 15, 2026 | accessdata.fda.gov |
| May 18, 2023 | P220013 | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | OAE | 32 | September 22, 2026 | accessdata.fda.gov |
| October 24, 2014 | P130026 | TACTICATH QUARTZ SET | OAE | 99 | August 7, 2026 | accessdata.fda.gov |
| May 28, 2014 | P100045 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | MOM | 90 | September 30, 2026 | accessdata.fda.gov |
| January 25, 2012 | P110016 | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | OAD | 91 | August 7, 2026 | accessdata.fda.gov |
| March 16, 2007 | P060019 | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | OAD | 55 | August 7, 2026 | accessdata.fda.gov |
| November 18, 2005 | P040042 | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER | OAD | 57 | September 3, 2026 | accessdata.fda.gov |
| January 14, 2005 | P040014 | IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR | LPB | 50 | September 3, 2026 | accessdata.fda.gov |
| May 4, 1999 | P960016 | LIVEWIRE(R) CARDIAC ABLATION SYSTEM | LPB | 89 | August 7, 2026 | accessdata.fda.gov |
| September 30, 1996 | P930038 | Angio Seal Vascular Closure Device | MGB | 99 | August 4, 2026 | accessdata.fda.gov |
| February 28, 1989 | P880006 | SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM | DXY | 86 | February 12, 2016 | 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 10, 2026 | 99844 | Class II | Ongoing | Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034 | Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). | accessdata.fda.gov |
| September 10, 2025 | 97595 | Class I | Ongoing | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. | accessdata.fda.gov |
| March 17, 2025 | 96545 | Class II | Ongoing | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 | Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism. | accessdata.fda.gov |
| September 28, 2023 | 93152 | Class II | Ongoing | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure. | accessdata.fda.gov |
| June 12, 2023 | 92502 | Class I | Ongoing | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). | There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. | accessdata.fda.gov |
| June 9, 2022 | 90414 | Class II | Terminated | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation. | When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter." | accessdata.fda.gov |
| April 28, 2022 | 90106 | Class II | Terminated | FIRMap" Catheter, 60mm Basket | Incorrect product labeling. | accessdata.fda.gov |
| March 24, 2022 | 89872 | Class II | Terminated | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile. | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. | accessdata.fda.gov |
| November 16, 2021 | 89123 | Class II | Terminated | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length. | accessdata.fda.gov |
| November 9, 2021 | 89714 | Class II | Terminated | Amplatzer Steerable Delivery Sheath | Instructions for use were updated. | accessdata.fda.gov |
| May 22, 2020 | 85775 | Class II | Terminated | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip desig | High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter | accessdata.fda.gov |
| December 9, 2019 | 84459 | Class II | Terminated | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, | Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. | accessdata.fda.gov |
| December 9, 2019 | 84454 | Class II | Terminated | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 | Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. | accessdata.fda.gov |
| November 11, 2019 | 84295 | Class II | Terminated | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet | A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas. | accessdata.fda.gov |
| October 14, 2019 | 84272 | Class II | Terminated | Radiofrequency Grounding Pad, REF RF-DGP-L | Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating. | accessdata.fda.gov |
| October 11, 2013 | 66597 | Class II | Terminated | US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irriga | St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU). | accessdata.fda.gov |
| October 11, 2013 | 66574 | Class II | Terminated | Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treat | St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended. | accessdata.fda.gov |
| December 17, 2010 | 57819 | Not yet classified | Terminated | AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defect | AGA Medical is initiating a voluntary recall of a specific lot of mislabeled AMPLATZER Sizing Balloon II. AGA Medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. The proper sizing (24 mm) was printed on the device hub visible through the product package. | accessdata.fda.gov |
| December 18, 2009 | 54369 | Not yet classified | Terminated | AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introduci | In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use. | accessdata.fda.gov |
| April 25, 2008 | 48650 | Not yet classified | Terminated | AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. M | AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devic | accessdata.fda.gov |
| October 2, 2006 | 36440 | Not yet classified | Terminated | Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-4 | AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode. | accessdata.fda.gov |
| June 1, 2006 | 35814 | Not yet classified | Terminated | AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporati | AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees. | accessdata.fda.gov |
| September 6, 2005 | 33406 | Not yet classified | Terminated | AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct | The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream. | accessdata.fda.gov |
| September 1, 2005 | 33323 | Not yet classified | Terminated | AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place | Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed. | accessdata.fda.gov |
| November 23, 2004 | 30481 | Not yet classified | Terminated | Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading de | Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. | accessdata.fda.gov |
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Updated October 16, 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.