Data / Medical devices / United States / Abbott Medical
Abbott Medical: FDA-registered device maker in Sylmar, CA, United States, 44 510(k) clearances and 11 PMA approvals
Abbott Medical is registered with the FDA (registration 2017865) in Sylmar, CA, United States. It lists 33 device types. The FDA files 44 510(k) clearances and 11 PMA approvals under its listings, the newest dated December 18, 2025. 38 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2017865
- Address
- 15900 Valley View Court, Sylmar, CA, United States, 91342
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Contract sterilizer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 17, 2001
- Registered through
- 2027
- Brand names listed
- 410170, 410171, 410172, 410173, 410174, 410175, 410176, 410177, 410180, 410181, 410182, 410183, 410184, 410185, 410186, 410187, 410210, 410211, 410212, 410213, 410214, 410215, 410216, 410224, 410217, 410218, 410219, 410220, 410221, 410222, 410223, 410225, 410193, 410194, ACCENT ST MRI, AVEIR AR 2 Leadless Pacemaker - Model LSP203A, AVEIR VR MINI Leadless Pacemaker- Model LSP203V, Accent MRI, Accent; Sustain XL SC, DC, SR, DR; 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 18, 2025 | K253516 | Assert-IQ (DM5100) | MXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 17, 2025 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | MXD | Substantially Equivalent | Abbott | accessdata.fda.gov |
| June 2, 2023 | K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029) | DQY | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 17, 2023 | K230286 | Assert-IQ Insertable Cardiac Monitor | MXC | 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 |
| June 30, 2022 | K221750 | CPS AIM Universal II Slittable Inner Catheter | DQY | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 1, 2022 | K213494 | Aveir Retrieval Catheter | MMX | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| August 13, 2021 | K212206 | Jot Dx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| July 27, 2021 | K211989 | Aveir Introducer | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 1, 2020 | K202876 | Confirm Rx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| November 23, 2020 | K202888 | Confirm Rx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| June 3, 2020 | K200721 | Agilis HisPro Steerable Catheter With Electrodes | DQY | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| March 17, 2020 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | MXC | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| October 18, 2019 | K192593 | Confirm Rx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott | accessdata.fda.gov |
| April 10, 2019 | K190295 | Confirm Rx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott (St. Jude Medical) | accessdata.fda.gov |
| March 29, 2019 | K182981 | Confirm Rx Insertable Cardiac Monitor | MXC | Substantially Equivalent | Abbott | accessdata.fda.gov |
| November 2, 2017 | K173232 | myMerlin(TM) Mobile Application Model APP1001 | MXC | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 29, 2017 | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | MXC | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| May 19, 2016 | K161102 | Nanostim Introducer Kit | DYB | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| April 14, 2016 | K160716 | The Nanostim Introducer Kit | DYB | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| December 18, 2014 | K142239 | CPS Direct MediGuide Enabled outer catheter | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 18, 2014 | K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 17, 2014 | K140793 | NANOSTIM INTRODUCER KIT | DYB | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| May 28, 2014 | K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | MXC | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| March 20, 2013 | K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| March 20, 2013 | K130252 | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 28, 2012 | K122161 | SJM CONFIRM | MXC | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| November 15, 2012 | K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | MXC | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| May 11, 2012 | K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | DQY | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| May 8, 2012 | K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE | DQX | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| January 19, 2011 | K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | DQY | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| December 21, 2010 | K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | DTA | Substantially Equivalent | St Jude Medical, Crmd | accessdata.fda.gov |
| September 15, 2010 | K101968 | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | MXC | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 2, 2010 | K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A | DSA | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| August 7, 2009 | K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 | DQY | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| July 1, 2009 | K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 | DQY | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| April 1, 2009 | K090163 | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | DRB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 12, 2008 | K082932 | CPS AIM SL SLITTABLE INNER CATHETER | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 15, 2008 | K081365 | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR | MXC | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 30, 2008 | K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | DRB | Substantially Equivalent | St. Jude Medical, Cardiac Rhythm Management Divisi | accessdata.fda.gov |
| July 14, 2006 | K061710 | CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| February 24, 2006 | K053277 | CPS DIRECT SL OUTER CATHETER | DQY | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 6, 1995 | K950140 | IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 | DTD | Substantially Equivalent | Pacesetter, Inc. | accessdata.fda.gov |
| August 3, 1992 | K921318 | ADAPTING SLEEVE KIT MODEL 4023 | DTD | Substantially Equivalent | Siemens-Pacesetter, 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 |
|---|---|---|---|---|---|---|
| March 31, 2022 | P150035 | Aveir VR Leadless System | PNJ | 42 | October 21, 2026 | accessdata.fda.gov |
| January 31, 2017 | P140033 | Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software | LWP | 100 | July 21, 2026 | accessdata.fda.gov |
| June 30, 2004 | P030054 | ST JUDE MEDICAL EPIC HF SYSTEM | NIK | 427 | August 12, 2026 | accessdata.fda.gov |
| May 13, 2004 | P030035 | ANTHEM AND FRONTIER II CRT-P'S | NKE | 202 | July 21, 2026 | accessdata.fda.gov |
| December 21, 2000 | P970013 | MICRONY PACEMAKERS | LWO | 94 | July 21, 2026 | accessdata.fda.gov |
| January 29, 1998 | P960030 | PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS | NVN | 81 | June 26, 2026 | accessdata.fda.gov |
| June 20, 1997 | P960013 | TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS | NVN | 130 | October 9, 2026 | accessdata.fda.gov |
| May 10, 1996 | P950022 | TVL(TM) LEAD SYSTEM | LWS | 145 | June 26, 2026 | accessdata.fda.gov |
| April 30, 1993 | P910023 | CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM | LWS | 461 | August 12, 2026 | accessdata.fda.gov |
| August 21, 1989 | P880086 | ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS | DXY | 328 | July 21, 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 |
|---|---|---|---|---|---|---|
| May 12, 2026 | 98963 | Class II | Ongoing | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. | accessdata.fda.gov |
| February 15, 2025 | 96411 | Class II | Ongoing | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadle | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. | accessdata.fda.gov |
| November 21, 2024 | 95813 | Class II | Ongoing | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing. | accessdata.fda.gov |
| October 1, 2024 | 95557 | Class III | Ongoing | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitorin | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. | accessdata.fda.gov |
| February 5, 2024 | 94072 | Class II | Ongoing | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | accessdata.fda.gov |
| August 16, 2023 | 92923 | Class II | Ongoing | Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with l | accessdata.fda.gov |
| June 17, 2022 | 90530 | Class II | Ongoing | Merlin PCS 3650 programmer Model 3330 software | There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. | accessdata.fda.gov |
| March 10, 2022 | 89825 | Class II | Ongoing | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity. | accessdata.fda.gov |
| March 10, 2022 | 89816 | Class II | Ongoing | Merlin PCS 3650 programmer Model 3330 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing paramete | accessdata.fda.gov |
| March 15, 2021 | 87558 | Class I | Ongoing | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing. | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough | accessdata.fda.gov |
| February 28, 2020 | 85275 | Class II | Terminated | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and t | Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained. | accessdata.fda.gov |
| January 22, 2020 | 84849 | Class II | Terminated | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377- | Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely. | accessdata.fda.gov |
| June 20, 2019 | 83252 | Class I | Terminated | ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices. | accessdata.fda.gov |
| November 19, 2018 | 82536 | Class II | Terminated | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data | The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. | accessdata.fda.gov |
| April 16, 2018 | 80244 | Class II | Terminated | St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: di | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery | accessdata.fda.gov |
| April 16, 2018 | 80212 | Class II | Terminated | Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239 | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers | accessdata.fda.gov |
| April 13, 2018 | 84453 | Class II | Terminated | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylma | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | accessdata.fda.gov |
| August 28, 2017 | 78093 | Class II | Terminated | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. | accessdata.fda.gov |
| August 28, 2017 | 78068 | Class I | Terminated | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model N | The device may exhibit premature battery depletion. | accessdata.fda.gov |
| October 10, 2016 | 75393 | Class I | Terminated | Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-4 | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit. | accessdata.fda.gov |
| March 31, 2016 | 73837 | Class II | Terminated | Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defi | St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. | accessdata.fda.gov |
| November 3, 2015 | 72569 | Class I | Terminated | Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD). | Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil. | accessdata.fda.gov |
| August 18, 2015 | 71995 | Class II | Terminated | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's. | Some devices exhibit backup VVI operation due to a backup reset. | accessdata.fda.gov |
| December 18, 2014 | 70066 | Class II | Terminated | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter | Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers. | accessdata.fda.gov |
| August 19, 2014 | 69087 | Class II | Terminated | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309 | An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert. | accessdata.fda.gov |
| April 3, 2012 | 61656 | Not yet classified | Terminated | Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lea | Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads. | accessdata.fda.gov |
| November 28, 2011 | 60571 | Not yet classified | Terminated | St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrill | St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors. | accessdata.fda.gov |
| September 23, 2011 | 60134 | Not yet classified | Terminated | Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false. | accessdata.fda.gov |
| March 31, 2011 | 58686 | Not yet classified | Terminated | SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms | The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade | accessdata.fda.gov |
| January 16, 2008 | 46870 | Not yet classified | Terminated | Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197 | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially | accessdata.fda.gov |
| March 20, 2007 | 37818 | Not yet classified | Terminated | St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126. | Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure. | accessdata.fda.gov |
| October 6, 2006 | 36619 | Not yet classified | Terminated | St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510 | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status. | accessdata.fda.gov |
| June 1, 2006 | 35616 | Not yet classified | Terminated | CPS Slitter, Model 410191 | Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process. | accessdata.fda.gov |
| October 6, 2005 | 33807 | Not yet classified | Terminated | Photo DR, Model V-230HV Implantable Cardioverter Defibrillator | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. | accessdata.fda.gov |
| June 17, 2005 | 32465 | Not yet classified | Terminated | Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343). | Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade. | accessdata.fda.gov |
| March 10, 2005 | 31515 | Not yet classified | Terminated | Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 a | Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery. | accessdata.fda.gov |
| July 31, 2003 | 27045 | Not yet classified | Terminated | Pulse Generator | Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals. | accessdata.fda.gov |
| November 4, 2002 | 25102 | Not yet classified | Terminated | Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256 | Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1 | accessdata.fda.gov |
Compare with other makers
- All makers of Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
- All makers of Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- All makers of Programmer, Pacemaker
- All makers of Implantable Pulse Generator, Pacemaker (Non-Crt)
- All makers of Pulse Generator, Permanent, Implantable
Updated October 21, 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.