Urgent Field Safety Notice For Accolade Family Of Pacemakers & Crt-ps By Cardiac Pacemaker Inc.- A Wholly Owned Subsidiary Of Guidant Corporation - A Wholly Owned Subsidiary
Recall Summary Cardiac Pacemaker Inc. (a Guidant subsidiary) has issued an urgent safety notice for ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The notice was classified as Class I, indicating a serious safety concern. The affected devices were distributed in Germany and the EU.
- Recalling firm
- Cardiac Pacemaker Inc.- A wholly owned subsidiary of Guidant Corporation - A wholly owned subsidiary
- Product
- ACCOLADE family of pacemakers & CRT-Ps
- Reason
- Urgent Field Safety Notice for ACCOLADE family of pacemakers & CRT-Ps by Cardiac Pacemaker Inc.- A wholly owned subsidiary of Guidant Corporation - A wholly owned subsidiary
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-09
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/8ae2bc32-bf05-4ed8-b966-7e200514c289