Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Brand(s)
Summary
Contact manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
---|---|---|
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump |
More than 10 numbers, contact manufacturer. |
0998-00-0800-XX |
Issue
There is a potential for the following 4 issues to occur: 1. unexpected shutdown due to failure of the connection with the coiled cable cord (serial numbers specific); 2. unexpected shutdown due to loss of communication between the executive processor PCBA and the video generator PCBA resulting in code 111/code 112; 3. helium leak due to the high pressure helium regulator; 4. helium leak due to a worn, torn or damaged o-ring on the quick disconnect fitting.
Recall start date: February 10, 2023
Additional information
Details
Datascope Corp.
1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
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