FDA Device Recall Z-0442-2023

ARROW INTERNATIONAL Inc. · Morrisville, NC

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

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

Lot / serial / GTIN: UDI/DI (01) 1 0801902 18178 4, (01) 1 0801902 18178 7, All Lot/Serial Numbers

Quantity: N/A

Reason for recall

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Recall record

Recall number: Z-0442-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2022-10-17
Classified by FDA Center: 2022-12-15
FDA published: 2022-12-21
Recalling firm: ARROW INTERNATIONAL Inc.
Firm location: Morrisville, NC

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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