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 | IC2034 | 0042-0000-CA |
| Impella Controller | IC1572 | 0042-0000-CA |
| Impella Controller | IC2369 | 0042-0000-CA |
| Impella Controller | IC2370 | 0042-0000-CA |
| Impella Controller | IC1715 | 0042-0000-CA |
| Impella Controller | IC4944 | 0042-0000-CA |
| Impella Controller | IC1480 | 0042-0000-CA |
| Impella Controller | IC1544 | 0042-0000-CA |
| Impella Controller | IC2032 | 0042-0000-CA |
| Impella Controller | IC1665 | 0042-0000-CA |
| Impella Controller | IC1098 | 0042-0000-US |
Issue
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.
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-78096
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