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Cardiosave Hybrid and rescue IABP

FDA Recall #Z-1248-2016 — Class II — December 16, 2015

Recall #Z-1248-2016 Date: December 16, 2015 Classification: Class II Status: Terminated

Product Description

Cardiosave Hybrid and rescue IABP

Reason for Recall

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

Recalling Firm

Maquet Datascope Corp - Cardiac Assist Division — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1243 units US; 1107 units OUS

Distribution

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Code Information

Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Status

Terminated

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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