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.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Abbott Medical Abbott Infinity 5 and Infinity 7 Implantable Pulse Generators [HKMD No.: 210488].
According to the FDA, there is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94796
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 29 Jul 2024