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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