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 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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