Recall Z-1590-2023— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2023-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US). Reason: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-04-17
- Firm location
- Danvers, MA, United States
Product description
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Reason for recall
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.