Automated Impella® Controller
Brand(s)
Last updated
Summary
Product
Automated 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 catalogue number |
|---|---|---|
| Automated Impella® Controller | IC2369 | 0042-0000-CA |
| Automated Impella® Controller | IC2370 | 0042-0000-CA |
| Automated Impella® Controller | IC1572 | 0042-0000-CA |
| Automated Impella® Controller | IC2686 | 0042-0000-CA |
| Automated Impella® Controller | CI1665 | 0042-0000-CA |
| Automated Impella® Controller | IC1544 | 0042-0000-CA |
| Automated Impella® Controller | IC2687 | 0042-0000-CA |
Issue
Abiomed, Inc. has initiated a voluntary medical device recall (removal) of specific Automated Impella® Controllers (AIC) (Product Code: 0042-0000-CA). A retrospective review of servicing records identified that certain AIC units require specific hardware updates to address potential safety concerns. These updates are intended to mitigate risks that could lead to a delay or loss of hemodynamic support, which may result in serious injury or death.
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
Recall date
Identification number
RA-81986
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