Leadless Pacemaker
FDA adverse event reports and recall history for leadless pacemaker (product code PNJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 19,472
- Deaths
- 1,236
- Injuries
- 7,634
- Malfunctions
- 10,601
Reports per year
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-11Open, ClassifiedSoftware Design Change
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.
- 2025-04-14Open, ClassifiedProcess control
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 Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
- 2024-12-23Open, ClassifiedUnder Investigation by firm
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, display data from, and test Abbott Medical implantable devices and leads.
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.
- 2024-04-29Open, ClassifiedDevice Design
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
- 2019-09-09TerminatedOther
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
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 to release the Micra Pacemaker from the Micra Delivery System during implant.
- 2019-09-09TerminatedOther
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 include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
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