No image published for this recall
The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
An official Health Canada notice concerns Impella® controller. Abiomed has identified specific automated Impella® controller in the field that have a pump driver circuit assembly that does not meet current specifications. These pump driver circuit assemblies contain 25v-rated tantalum capacitors instead of 35v-rated. These underrated capacitors may lead to decreased pump performance or pump stop and trigger an "Impella failure" or "Impella stopped. Controller failure." alarm. Recall start date: August 27, 2025 Published 2025-08-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78001
Official notice
2025-08-29
The hazard
The hazard
Abiomed has identified specific automated Impella® controller in the field that have a pump driver circuit assembly that does not meet current specifications. These pump driver circuit assemblies contain 25v-rated tantalum capacitors instead of 35v-rated. These underrated capacitors may lead to decreased pump performance or pump stop and trigger an "Impella failure" or "Impella stopped. Controller failure." alarm. Recall start date: August 27, 2025
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
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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