Leadless Pacemaker
FDA product code PNJ · Class III (high risk) · 21 CFR 870.3610 · Cardiovascular
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
0510(k) clearances
2PMA approvals
6recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2405-2026 Class II | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareSoftware malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not… | Abbott Medical | 05/12/2026Open, Classified |
| Z-1557-2025 Class II | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code:…Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures… | Abbott Medical | 02/15/2025Open, Classified |
| Z-0753-2025 Class II | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a…Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific… | Abbott Medical | 11/21/2024Open, Classified |
| Z-1695-2024 Class II | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOTheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | Abbott Medical | 02/05/2024Open, Classified |
| Z-2493-2019 Class II | Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to… | Medtronic Inc., Cardiac Rhythm and Heart… | 08/06/2019Terminated |
| Z-2492-2019 Class II | Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US…Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to… | Medtronic Inc., Cardiac Rhythm and Heart… | 08/06/2019Terminated |