Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump recall
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Why was Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump recalled?
Power supply malfunction complaints related to suboptimal thermal management.
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?
0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
- Product
- Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Quantity
- 1,300 units
- Distribution
- US Nationwide distribution
- Recall date
- March 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)