Urgent Field Safety Notice For Automated Impella Controller By Abiomed Inc.
Recall Summary ABIOMED Inc. has issued an urgent safety notice for the Automated Impella Controller, a Class I device distributed in Germany and the EU. The notice addresses a risk assessment finding that requires corrective field actions. This recall affects patients and healthcare facilities using this cardiac support device in the specified regions.
- Recalling firm
- ABIOMED Inc.
- Product
- Automated Impella Controller
- Reason
- Urgent Field Safety Notice for Automated Impella Controller by ABIOMED Inc.
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-07-03
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/e342c7ab-3b3d-4c61-addb-73da662ab4af