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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 product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
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Product 9
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Product 11
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
Brand: Abiomed, Impella Controller.
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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