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 manufacturer if you require additional information.
Audience
Healthcare
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
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-72688
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