Device product

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Z-2319-2024

May 31, 2024

Class I

Product summary

Firm: Abiomed, Inc.
Event: Event 94833
Status: Ongoing
Classification: Class I
Quantity: 9 units
Official record key: device-enforcement:Z-2319-2024

Official wording

Reason: Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Code information: Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.

Distribution pattern: Domestic only: FL, MA, OH TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Nine (9) Impella CP pumps failed inspection and were inadvertently released.