Reported Nov 4, 2026 · Ongoing
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure"…
Medtronic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic, Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- 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.
- Lot codes and dates
- 3930M74 UDI-DI 00763000643430, 00763000643447, 00763000759919, 00199150001187 Serial Nos.UDI-DI 00763000643454, 00763000643461, 00199150001170 Serial Nos.
510 of 510 codes
CDD401008VCDD401100VCDD401499VCDD401655VCDD401951VCDD402630VCDD402652VCDD402658VCDD402681VCDD403969VCDD403996VCDD404002VCDD404005VCDD404010VCDD404013VCDD404049VCDD404050VCDD404068VCDD404095VCDD404096VCDD404102VCDD404103VCDD404104VCDD404107VCDD404164VCDD404177VCDD408398VCDD408399VCDD408405VCDD408407VCDD408411VCDD408414VCDD408425VCDD409092VCDD409098VCDD409099VCDD409132VCDD409134VCDD409164VCDD409168VCDD409220VCDD409225VCDD409226VCDD409891VCDD409892VCDD409894VCDD409895VCDD409896VCDD409909VCDD409910VCDD409914VCDD409937VCDD409949VCDD409950VCDD409951VCDD409999VCDD410008VCDD410574VCDD410583VCDD410597V
208 of 208 codes
CDD604403VCDD604404VCDD604414VCDD604418VCDD604489VCDD604494VCDD604496VCDD604497VCDD604498VCDD604499VCDD604502VCDD604505VCDD604507VCDD604538VCDD604540VCDD606023VCDD606029VCDD606033VCDD606043VCDD606077VCDD606078VCDD606081VCDD606083VCDD606084VCDD606086VCDD606088VCDD606089VCDD606090VCDD606091VCDD606095VCDD606112VCDD606118VCDD606119VCDD606120VCDD606121VCDD606122VCDD606123VCDD606125VCDD606126VCDD606127VCDD606128VCDD606130VCDD606131VCDD606132VCDD606133VCDD606135VCDD606137VCDD606139VCDD606140VCDD606142VCDD606143VCDD606144VCDD606145VCDD606146VCDD606147VCDD606149VCDD606151VCDD606159VCDD606161VCDD606163V
- 3930M74 UDI-DI 00763000643430, 00763000643447, 00763000759919, 00199150001187 Serial Nos.
- Amount recalled
- 717
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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