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 catalogue number |
|---|---|---|
| Impella Controller | Software V6.0.1–6.0.3 and ≥7.1 | 0042-0040-CA |
| Impella Controller | Software V6.0.1–6.0.3 and ≥7.1 | 0042-0000-CA |
Issue
Abiomed, Inc. has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.
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-82061
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