FDA Medical devices recall ·
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79… recall
- Recall number
- Z-0285-2027
- Date
- (initiated September 17, 2026)
- Company / brand
- Medtronic, Inc.
8200 Coral Sea St Ne, Mounds View, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 717
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
3930M74 UDI-DI 00763000643430, 00763000643447, 00763000759919, 00199150001187 Serial Nos. CDD401008V CDD401100V CDD401499V CDD401655V CDD401951V CDD402630V CDD402652V CDD402658V CDD402681V CDD403969V CDD403996V CDD404002V CDD404005V CDD404010V CDD404013V CDD404049V CDD404050V CDD404068V CDD404095V CDD404096V CDD404102V CDD404103V CDD404104V CDD404107V CDD404164V CDD404177V CDD408398V CDD408399V CDD408405V CDD408407V CDD408411V CDD408414V CDD408425V CDD409092V CDD409098V CDD409099V CDD409132V CDD409134V CDD409164V CDD409168V CDD409220V CDD409225V CDD409226V CDD409891V CDD409892V CDD409894V CDD409895V CDD409896V CDD409909V CDD409910V CDD409914V CDD409937V CDD409949V CDD409950V CDD409951V CDD409999V CDD410008V CDD410574V CDD410583V CDD410597V CDD410602V CDD410611V CDD410613V CDD410614V CDD410615V CDD410616V CDD410617V CDD410634V CDD410635V CDD410641V CDD410656V CDD410748V CDD410749V CDD410750V CDD410752V CDD410753V CDD410756V CDD410757V CDD410758V CDD410760V CDD410761V CDD410762V CDD410763V CDD410792V CDD410836V CDD410848V CDD410875V CDD410908V CDD410938V CDD410958V CDD410959V CDD410982V CDD410983V CDD410987V CDD411007V CDD411013V CDD411014V CDD411016V CDD411749V CDD411760V CDD411780V CDD411782V CDD411795V CDD411805V CDD412823V CDD412825V CDD412829V CDD412837V CDD412838V CDD412839V CDD412843V CDD412847V CDD412851V CDD412855V CDD412860V CDD412869V CDD412871V CDD412872V CDD412873V CDD412874V CDD412876V CDD412877V CDD412882V CDD412883V CDD412884V CDD412885V CDD412888V CDD412892V CD
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, Japan, New Zealand, Poland, Reunion, Slovenia, Spain, Sweden, United Kingdom.
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0285-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.