FDA Device Recall Z-2319-2024

Abiomed, Inc. · Danvers, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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.

Quantity: 9 units

Reason for recall

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

Recall record

Recall number: Z-2319-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: Domestic only: FL, MA, OH TX.
Recall initiated: 2024-05-31
Classified by FDA Center: 2024-07-17
FDA published: 2024-07-24
Recalling firm: Abiomed, Inc.
Firm location: Danvers, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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