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Impella controller
Official notice
18 Sept 2025
Last checked
18 Sept 2025
An official Health Canada notice concerns Impella controller. Abiomed has decided to initiate a voluntary medical device recall (removal) for Automated Impella Controllers (AICs) in the field related to a design change that improves the AIC purge retainer fixture and addresses potential purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the AIC may need to be replaced. Published 2025-09-18.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78096
Official notice
2025-09-18
The hazard
The hazard
Abiomed has decided to initiate a voluntary medical device recall (removal) for Automated Impella Controllers (AICs) in the field related to a design change that improves the AIC purge retainer fixture and addresses potential purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the AIC may need to be replaced.
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
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Phone
Brand: Abiomed, Impella Controller.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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