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Absolute pro ll .035 peripheral self-expanding stent system

Official notice

30 May 2022

Last checked

30 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Absolute pro ll .035 peripheral self-expanding stent system. 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 Published 2022-05-30.

What to do now

Contact manufacturer if you require additional information.

Recall number

64214

Official notice

2022-05-30

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64214

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Affected products

Product 1

Affected products - Absolute Pro Ll .035 Peripheral Self-Expanding Stent System, Lot or Serial number - More than 10 numbers, contact manufacturer., Model or Catalogue number - 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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Abbott Vascular, Absolute Pro Ll 035 Peripheral Self-expanding Stent System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64214

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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