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, has issued a medical device safety alert concerning its subset of Assurity and Endurity Pacemakers [Model: PM2152, PM2162, PM2172, PM2272]. [HKMD No.: 160029, 160055].
The manufacturer is informing clinicians of the potential for device malfunction due to a manufacturing issue which may affect a limited subset of 455 Assurity and Endurity pacemakers. The issue has been associated with interrupted functionality such as loss of pacing, reduced battery longevity, reverting to back-up mode, loss of telemetry/ communication, and/or shortened duration between Elective Replacement Indicator (ERI) and End of Service (EOS). The manufacturer’s product performance surveillance processes have identified nine (9) devices affected by a manufacturing process variation within a single piece of equipment resulting in the potential for moisture ingress into the pulse generator. Reported clinical symptoms ranged from no patient clinical signs to transient patient symptoms (discomfort, dizziness, dyspnea, arrhythmia). The affected devices were manufactured between August 2018 and November 2019. The equipment which led to this issue is no longer part of the device manufacturing.
Affected users should follow the action listed on the customer letter issued by the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Oct 2023