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Aveir™
ST. JUDE MEDICAL, INC. · Model LSP201A · UDI-DI 05415067040701
PNJ
Prescription
0
510(k) clearances
20,449
Adverse events (1,282 deaths)
6
Recalls
11
Facilities
Description
Leadless Pacemaker
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 terminate the test. |
| 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 telemetry during a small |
| 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 to release the Micr |
| 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 to release the Micr |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.