Medtronic, Inc.: Permanent Defibrillator Electrodes
Recall Summary Medtronic is recalling two models of permanent defibrillator leads (Model 3930M, in 74 cm and 79 cm versions) distributed nationwide and internationally because doctors have reported difficulty securing them properly during implant surgery, which could cause tissue damage. The leads are designed to help regulate heart rhythm and deliver defibrillation therapy in patients with implantable defibrillators. Medtronic is conducting additional engineering evaluation on these products due to the implantation issues.
- Recalling firm
- Medtronic, Inc.
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/19b32e84-ef62-40cf-b2ef-79e026ab3c05