Cardiosave Hybrid Intra-Aortic Balloon Pumps recall: Software Issue
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Why was Cardiosave Hybrid Intra-Aortic Balloon Pumps recalled?
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
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-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Recalling firm
- Datascope Corp.
- Quantity
- 4 units
- Distribution
- International distribution in the country of Germany.
- Recall date
- June 21, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)