Health product recall

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
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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