FDAClass IIMarch 8, 2017

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP recall

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product…

Why was CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP recalled?

Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

part number 0146-00-0097

Product
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product…
Recalling firm
Maquet Datascope Corp - Cardiac Assist Division
Quantity
8000
Distribution
Worldwide Distribution - US Nationwide
Recall date
March 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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