Impella® Controller
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Abiomed Inc.
22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923
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