Cardiosave Hybrid IABP recall
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Why was Cardiosave Hybrid 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 - 10607567108391 All Serial Numbers
- Product
- Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
- 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)