Cardiosave Rescue IABP - Product Usage: used to inflate recall: Software Issue
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the…
Why was Cardiosave Rescue IABP - Product Usage: used to inflate recalled?
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
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 Systems. UDI: 10607567112312 10607567108407 10607567113449
- Product
- Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the…
- Recalling firm
- Datascope Corp.
- Quantity
- 10087 total
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- May 5, 2021
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)