Health product recall

Absolute Pro Ll .035 Peripheral Self-Expanding Stent System

Brand(s)
Last updated

Summary

Product
Absolute Pro Ll .035 Peripheral Self-Expanding Stent System
Issue
Medical devices - Performance issue
What to do

Contact manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or Serial number

Model or Catalogue number

Absolute Pro Ll .035 Peripheral Self-Expanding Stent System

More than 10 numbers, contact manufacturer.

1012083-120
1012084-120
1012087-120
1012087-150
1012082-120
1012082-150
1012085-120
1012086-120
1012085-150
1012086-150
1012088-120
1012089-120
1012088-150
1012083-150
1012084-150
1012089-150

Issue

Abbott has confirmed reports of mechanical locking, stent deployment, and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent. To reduce occurrences of deployment failures and associated outcomes, Abbott is notifying all users of the potential causes and risks. This action does not affect patients having successfully undergone procedures using these devices.

Recall start date: May 24, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Abbott Vascular

3200 Lakeside Drive, Santa Clara, California, United States, 95054-2807

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64214

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