Impella CP With SmartAssist and Impella 5.5 With SmartAssist
Brand(s)
Last updated
Summary
Product
Impella CP With SmartAssist and Impella 5.5 With SmartAssist
Issue
Medical devices - Device compatibility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Impella CP With SmartAssist |
All lots. |
0048-0044 |
Impella 5.5 With SmartAssist |
All lots. |
0550-0004 |
Issue
Abiomed has determined there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with shockwave coronary intra-vascular lithotripsy catheter.
Recall Start Date: September 3, 2024
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-76002
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