🇨🇦 InterStim™ Systems

Hazard/Reason: Medtronic has received 15 complaints involving the selection of an incompatible component based on the intended system configuration between 01-Jan-2020 through 12-Aug-2026. Use of an incompatible lead or percutaneous extension has resulted in a delay of surgery or the need for surgical replacement of the component. Review of complaint data confirmed that the product is functioning as designed and there are no device or product performance issues.

This page links to official sources. Verify model/lot/batch details in the official notice.