FDAClass INovember 7, 2018

Cardiosave Rescue IABP recall

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

Why was Cardiosave Rescue IABP recalled?

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI - 10607567108407 All Serial Numbers

Product
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Recalling firm
Maquet Datascope Corp - Cardiac Assist Division
Quantity
N/A
Distribution
US Nationwide; Internationally to 77 countries
Recall date
November 7, 2018
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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