fda_recall · device_recall · critical

Abiomed, Inc. — Class I recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro…

Event date
2026-07-01 00:00:00Z
Observed
2026-07-09 22:51:53Z
Source ID
Z-2600-2026
Payload hash
da35766eecf2ef2595b969df

Summary

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

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