Health product recall

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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