FDA recall, , Moderate risk
Medtronic OmniaSecure Model 3930M Leads
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation.
Summary by Recall Canary from the FDA notice
What happened
Medtronic, Inc. began a recall on September 17, 2026, of the OmniaSecure Model 3930M lead, including LEAD 3930M74 74 CM DF4 MR and LEAD 3930M79 79 CM DF4 MR, because affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. The potential harm is tissue trauma due to implant difficulty.
The lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode, designed for pacing, sensing, cardioversion, and defibrillation therapies.
The FDA added the recall to its Enforcement Report on October 23, 2026, with US Nationwide distribution including states such as Arizona, California, and Texas, and countries including Australia, Canada, and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Lead 3930M74 74 cm DF4 MR
- UDI-DI
- 00763000643430
- 00763000643447
- 00763000759919
- 00199150001187
- 00763000643454
- 00763000643461
- 00199150001170
Lead 3930M79 79 cm DF4 MR
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Arizona, California, Connecticut, Delaware, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and the countries of Australia, Canada, Canary Islands, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, New Zealand, Poland, Reunion, Slovenia, Spain, Sweden, United Kingdom.
- Company
- Medtronic, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99970
- Recall number
- Z-0285-2027
All recalls from Medtronic, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
