Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Brand(s)
Last updated
Summary
Product
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Datascope Corp.
1300 Macarthur Blvd., Mahwah, New Jersey, United States, 07430
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72511
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