Recall Z-2319-2024— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2024-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump. Reason: Nine (9) Impella CP pumps failed inspection and were inadvertently released..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-05-31
- Firm location
- Danvers, MA, United States
Product description
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Reason for recall
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Data sourced from openFDA. This site is unofficial and independent of the FDA.