Cardiosave Rescue Intra-Aortic Balloon Pump recall
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Why was Cardiosave Rescue Intra-Aortic Balloon Pump recalled?
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
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 lots
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Recalling firm
- Datascope Corp.
- Quantity
- 5054 total (US); 5033 total (OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)