fda_recall · device_recall · critical

Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro…

Event date
2026-07-01 00:00:00Z
Observed
2026-07-09 22:51:54Z
Source ID
Z-2599-2026
Payload hash
dfd3d39c169300132eb86266

Summary

Potential for thrombus formation during prolonged use of the introducer. Status: Ongoing.

Informational only. Not legal, financial, or medical advice.