Pulse Generator, Permanent, Implantable
FDA product code NVZ · Class III (high risk) · Cardiovascular
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
0510(k) clearances
5PMA approvals
40recalls
Implantimplanted device
PMA approvals
- P990001 Diva Platform Implantable Pulse Generators and Pro Vit Application Software Version 3.3.2 · Medtronic, Inc. · 09/27/1999
- P980035 Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software · Medtronic, Inc. · 01/29/1999
- P970012 Medtronic.Kappa 400 Series Pacemakers · Medtronic, Inc. · 01/30/1998
- P930022 Medtronic(R) Legend Plus(Tm) Pulse Generator · Medtronic, Inc. · 02/07/1997
- P890003 Synergyst II Pulse Generator Models 7070 & 7071 · Medtronic, Inc. · 08/24/1989
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2169-2025 Class II | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following…In prior SmartSync application versions, the Abort button stopped the test that was selected. During an… | Medtronic, Inc. | 06/18/2025Open, Classified |
| Z-2168-2025 Class II | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following…In prior SmartSync application versions, the Abort button stopped the test that was selected. During an… | Medtronic, Inc. | 06/18/2025Open, Classified |
| Z-1924-2025 Class II | Azure S DR MRI SureScan, Product number W3DR01Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets… | Medtronic, Inc. | 04/29/2025Open, Classified |
| Z-0552-2025 Class III | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with…Due to heart transmitter not being able to upgrade to the current software version in the field after… | Abbott Medical | 10/01/2024Open, Classified |
| Z-0551-2025 Class III | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to…Due to heart transmitter not being able to upgrade to the current software version in the field after… | Abbott Medical | 10/01/2024Open, Classified |
| Z-3152-2024 Class II | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product…Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for… | Medtronic Inc. | 07/11/2024Open, Classified |
| Z-0391-2022 Class II | Medical Device Identification Cards associated with Astra XT DR Implantable pulse…The back of some Medical Device Identification Cards provided to patients were printed with an erroneous… | Medtronic Inc., Cardiac Rhythm and Heart… | 11/08/2021Terminated |
| Z-1531-2021 Class I | ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm…Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of… | St. Jude Medical, Cardian Rhythm Management… | 03/15/2021Open, Classified |
| Z-1530-2021 Class I | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity…Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of… | St. Jude Medical, Cardian Rhythm Management… | 03/15/2021Open, Classified |
| Z-2513-2020 Class II | Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2512-2020 Class II | Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2511-2020 Class II | Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2510-2020 Class II | Azure S SR MRI, Model Number W3SR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2509-2020 Class II | Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2508-2020 Class II | Azure S DR MRI, Model Number W3DR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2507-2020 Class II | Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-2506-2020 Class II | Patient Connector, Model Number 24967There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/04/2020Open, Classified |
| Z-1351-2020 Class II | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC…Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to… | St Jude Medical, Cardiac Rhythm Management… | 01/22/2020Terminated |
| Z-0812-2019 Class I | vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b)…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0811-2019 Class I | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0810-2019 Class I | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0809-2019 Class I | Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0808-2019 Class I | Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0807-2019 Class I | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0806-2019 Class I | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model…A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019… | Medtronic Inc., Cardiac Rhythm and Heart… | 01/17/2019Open, Classified |
| Z-0400-2018 Class II | MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic…Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network… | Medtronic Inc., Cardiac Rhythm and Heart… | 07/14/2017Terminated |
| Z-0399-2018 Class II | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient…Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network… | Medtronic Inc., Cardiac Rhythm and Heart… | 07/14/2017Terminated |
| Z-2125-2016 Class II | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor…Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors.… | Medtronic Inc., Cardiac Rhythm and Heart… | 05/26/2016Terminated |
| Z-1605-2016 Class II | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B)…A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express… | Medtronic Inc., Cardiac Rhythm and Heart… | 03/31/2016Terminated |
| Z-2784-2015 Class II | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote…Some devices exhibit backup VVI operation due to a backup reset. | St Jude Medical Cardiac Rhythm Management… | 08/18/2015Terminated |
| Z-0949-2015 Class II | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M…Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical… | St Jude Medical Cardiac Rhythm Management… | 12/18/2014Terminated |
| Z-2120-2011 | Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are…A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices)… | Medtronic Inc. Cardiac Rhythm Disease… | 04/04/2011Terminated |
| Z-2209-2010 | Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is…Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software… | Medtronic Inc. Cardiac Rhythm Disease… | 06/11/2010Terminated |
| Z-1519-2009 | Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber…One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may… | Medtronic Inc. Cardiac Rhythm Disease… | 05/18/2009Terminated |
| Z-1515-2009 | Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate…One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may… | Medtronic Inc. Cardiac Rhythm Disease… | 05/18/2009Terminated |
| Z-1513-2009 | Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber…One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may… | Medtronic Inc. Cardiac Rhythm Disease… | 05/18/2009Terminated |
| Z-1511-2009 | Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Single Chamber…One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may… | Medtronic Inc. Cardiac Rhythm Disease… | 05/18/2009Terminated |
| Z-2235-2009 | Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin…Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the… | ela Medical Llc | 09/23/2008Terminated |
| Z-1000-2007 | Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a…Pacing rate: Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to… | Medtronic Inc. Cardiac Rhythm Managment | 02/05/2007Terminated |
| Z-0999-2007 | Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the…Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to… | Medtronic Inc. Cardiac Rhythm Managment | 02/05/2007Terminated |