Urgent Field Safety Notice For Impella 5.5 Smartassist By Abiomed Inc.

Recalling firm
ABIOMED Inc.
Product
Impella 5.5 SmartAssist
Reason
Urgent Field Safety Notice for Impella 5.5 SmartAssist by ABIOMED Inc.
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-12
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/00b30dde-d64d-4adb-b149-65917a4d68e3