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Cardiosave system - hybrid & rescue intra-aortic balloon pump
Official notice
17 Feb 2023
Last checked
17 Feb 2023
An official Health Canada notice concerns Cardiosave system - hybrid & rescue intra-aortic balloon pump. 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 Published 2023-02-17.
What to do now
Contact manufacturer if you require additional information.
Recall number
72688
Official notice
2023-02-17
The hazard
The hazard
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
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.
Recall Numbers
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Affected products
Product 1
Risk / hazard
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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Datascope, Cardiosave System - Hybrid Rescue Intra-aortic Balloon Pump.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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