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
Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood entering into the Cardiosave IABP when therapy is provided with a perforated intra-aortic balloon catheter.
Recall start date: December 21, 2022
Additional information
Details
Datascope Corp.
1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
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