Leadless Pacemaker
Cardiovascular · 21 CFR 870.3610
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Recent MDR events
19,964 adverse event reports on file
- Micra¿ AV2Jul 31, 2026MalfunctionMedtronic Ireland9612164-2026-03859
- Micra¿ AV2Jul 31, 2026DeathMedtronic Ireland9612164-2026-03860
- Micra¿ AV2Jul 31, 2026MalfunctionMedtronic Ireland9612164-2026-03861
- Micra¿ AV2Jul 31, 2026InjuryMedtronic Ireland9612164-2026-03862
- Micra¿ VR2Jul 31, 2026MalfunctionMedtronic Ireland9612164-2026-03863
- Micra¿ AV2Jul 31, 2026MalfunctionMedtronic Ireland9612164-2026-03869
- AVEIR AR 2 Leadless PacemakerJul 31, 2026MalfunctionAbbott Medical (crm-sylmar)2017865-2026-15849
- Aveir¿ Leadless Pacemaker, Right VentricleJul 31, 2026MalfunctionAbbott Medical (crm-sylmar)2017865-2026-16079
- AVEIR AR 2 Leadless PacemakerJul 31, 2026InjuryAbbott Medical (crm-sylmar)2017865-2026-16082
- Aveir¿ Leadless Pacemaker, Right VentricleJul 31, 2026InjuryAbbott Medical (crm-sylmar)2017865-2026-16083
Event type breakdown
Recalls
6 recall events for this product code
- Abbott MedicalOpen, ClassifiedJun 11, 2026
Merlin" Patient Care System (PCS) software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Z-2405-2026 · View FDA record ↗ - Abbott MedicalOpen, ClassifiedApr 14, 2025
Aveir DR Leadless Pacemaker (LP) Ventricular Device
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Z-1557-2025 · View FDA record ↗ - Abbott MedicalOpen, ClassifiedDec 23, 2024
The Merlin PCS 3650 programmer Model 3330
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.
Z-0753-2025 · View FDA record ↗ - Abbott MedicalOpen, ClassifiedApr 29, 2024
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Z-1695-2024 · View FDA record ↗ - Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)TerminatedSep 9, 2019
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.
Z-2492-2019 · View FDA record ↗ - Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)TerminatedSep 9, 2019
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.
Z-2493-2019 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Abbott Medical
Arecibo, PR, US
Benchmark Electronics, Inc.
WINONA, MN, US
Celestica
Valencia, ES
Medtronic Europe Sarl
TOLOCHENAZ Vaud, CH
Medtronic Distribution Center
Memphis, TN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Medtronic Ireland
GALWAY, IE
Abbott Medical
Minnetonka, MN, US
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Abbott Medical
Sylmar, CA, US
Medtronic, Inc.
Mounds View, MN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
2 premarket approvals for this product code