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 | Software version 8.2.3 | 0042-0040-CA |
| Automated Impella Controller | Software version 8.2.3 | 0042-0000-CA |
Issue
Abiomed has identified that Automated Impella Controller (AICS) with software V8.2.3, when used in conjunction with an Impella 5.5 with smart assist set (product code 0550-0004), has a delayed "purge system blocked" alarm. Software versions post-v10.1 have this issue addressed.
Abiomed recommends that you do not use the AIC with an Impella 5.5 with smart assist set (product code 0550-0004) unless AIC software is updated to v10.1 or above.
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-81652
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