Recall Z-0285-2027— Medtronic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic, Inc., initiated 2026-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.. Reason: Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty..
- Recalling firm
- Medtronic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-17
- Firm location
- Mounds View, MN, United States
Product description
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.
Reason for recall
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
Data sourced from openFDA. This site is unofficial and independent of the FDA.