OmniaSecure™ MRI SureScan™

Issue

Medtronic’s manufacturing quality processes identified a subset of OmniaSecure™ (Model 3930M) defibrillation leads which may have undergone a specific manufacturing sequence that requires these leads to be retrieved for additional engineering evaluation. As of 27 August 2026, Medtronic has received five (5) complaints associated with leads that underwent this specific manufacturing sequence. In each complaint, difficulty achieving fixation was reported during the implant procedure; none of the leads were implanted. There have been zero (0) reports of patient harm. If one of the identified lead(s) in this recall is implanted, there is no further action required beyond current standard of care. Medtronic will provide additional information, if appropriate, based on the ongoing engineering evaluation.