Impella® Controller
Brand(s)
Last updated
Summary
Product
Impella® Controller
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Impella® Controller | More than 10 numbers, contact manufacturer. | 0042-0040-CA |
| Impella® Controller | More than 10 numbers, contact manufacturer. | 0042-0000-CA |
Issue
Abiomed has identified an Automated Impella Controller™ (AIC) issue that may impair the detection of an Impella® pump when connected to an AIC. The pump detection issue may occur with any of the Abiomed Impella® pumps and may occur during console-to-console transfer or case start. There is no visual alarm displayed on the AIC screen to indicate the detection issue in these situations.
Recall start date: July 7, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77714
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