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Cardiosave system - hybrid & rescue intra-aortic balloon pump
Official notice
16 Mar 2023
Last checked
16 Mar 2023
An official Health Canada notice concerns Cardiosave system - hybrid & rescue intra-aortic balloon pump. 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 Published 2023-03-16.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73334
Official notice
2023-03-16
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Phone
Brand: Datascope, Cardiosave System - Hybrid Rescue Intra-aortic Balloon Pump.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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