Cardiosave Rescue Intra-Aortic Balloon Pumps recall
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Why was Cardiosave Rescue Intra-Aortic Balloon Pumps recalled?
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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?
All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Recalling firm
- Datascope Corp.
- Quantity
- 9175 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- September 6, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)