Recall Z-0285-2027 ยท NVY Permanent Defibrillator Electrodes
Medtronic, Inc.
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.
| Date | Oct 23, 2026 (initiated Sep 17, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | The firm began notifying consignees on September 17, 2026. Consignees were asked to quarantine and return any affected, unused product they may have, and complete and return the Customer Confirmation Form. |
| Quantity | 717 |
| Distribution | US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI, WV and the countries of Australia, Canada, Canary Islands, Finland, France, Germany, Greece, Ireland, Israel, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.