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Leadless Pacemaker
FDA product code PNJ · Class 3 · Cardiovascular
23
Registered devices
19,962
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
Entrant™ — ST. JUDE MEDICAL, INC.AVEIR™ — ST. JUDE MEDICAL, INC.Micra™ AV2 — MEDTRONIC, INC.AVEIR™ — ST. JUDE MEDICAL, INC.Neutrino™ — ST. JUDE MEDICAL, INC.Aveir™ — ST. JUDE MEDICAL, INC.Merlin.net — ST. JUDE MEDICAL, INC.Aveir™ — ST. JUDE MEDICAL, INC.Gallant™ — ST. JUDE MEDICAL, INC.Micra™ — MEDTRONIC, INC.Aveir™ — ST. JUDE MEDICAL, INC.AVEIR™ — ST. JUDE MEDICAL, INC.Micra™ VR2 — MEDTRONIC, INC.Entrant™ — ST. JUDE MEDICAL, INC.Aveir™ — ST. JUDE MEDICAL, INC.Aveir™ — ST. JUDE MEDICAL, INC.Gallant™ — ST. JUDE MEDICAL, INC.Neutrino™ — ST. JUDE MEDICAL, INC.Merlin™ — ST. JUDE MEDICAL, INC.Aveir™ — ST. JUDE MEDICAL, INC.AVEIR™ — ST. JUDE MEDICAL, INC.Micra™ AV — MEDTRONIC, INC.Micra™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | Abbott Medical | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminat |
| 2025-02-15 | Abbott Medical | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. |
| 2024-11-21 | Abbott Medical | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of tele |
| 2024-02-05 | Abbott Medical | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. |
| 2019-08-06 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 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 |
| 2019-08-06 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 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 |
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