Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Abbott Vascular, has issued a medical device safety alert concerning its Absolute Pro LL Peripheral Self-Expanding Stent System [Multiple Reference Number] [HKMD No.: 100271].
According to the manufacturer, it 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, the manufacturer is notifying all users of the potential causes and risks. This action does not affect patients having successfully undergone procedures using these devices.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 May 2022