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
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
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-73334
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