Cardiosave Hybrid and rescue IABP recall
Cardiosave Hybrid and rescue IABP
Why was Cardiosave Hybrid and rescue IABP recalled?
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.
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?
Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
- Product
- Cardiosave Hybrid and rescue IABP
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Quantity
- 1243 units US; 1107 units OUS
- Distribution
- Worldwide Distribution- Nationwide Distribution including Puerto Rico.
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)