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Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274)...

FDA Recall #Z-0440-2023 — Class I — October 17, 2022

Recall #Z-0440-2023 Date: October 17, 2022 Classification: Class I Status: Ongoing

Product Description

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump

Reason for Recall

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

Recalling Firm

ARROW INTERNATIONAL Inc. — Morrisville, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

N/A

Distribution

Worldwide

Code Information

UDI/DI (01) 2 0801902 14277 5, (01) 2 0801902 14277 8, All Lot/Serial Numbers

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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