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 | IC1544 | 0042-0000-CA |
| Impella® Controller | IC1543 | 0042-0000-CA |
Issue
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
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-78001
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