Urgent Field Safety Notice For Automated Impella Controller By Abiomed Inc.

Recall Summary ABIOMED Inc. is issuing an urgent safety notice for the Automated Impella Controller, a device distributed in Germany and the EU. The notice is classified as Class I, indicating a serious issue with the device. The specific reason for the recall has not been detailed in the information provided.

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
2026-09-01
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/752a28cb-0a88-4b21-81c8-d96473c0580d