Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump |
More than 10 numbers, contact manufacturer. |
0998-00-0800-XX |
Issue
While conducting safety disk testing, expired tubing was used on the test fixture equipment between April 01, 2022 and July 31, 2022. when using the obsoleted, and expired catheter extender tube, 0004-00-0033-01 during the static inflate/deflate test method can potentially lead to non-conforming bolted safety disks to pass the displacement test. This potential failure may lead to reduced IAB inflation during therapy.
Recall start date: March 6, 2023
Additional information
Details
Datascope Corp.
1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
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