FDA-Device2026-10-23Class IIPROCESSING DEFECT
Medtronic OmniaSecure Model 3930M ventricular lead recalled for implantation fixation difficulty
What this means
Medtronic has recalled certain OmniaSecure Model 3930M ventricular leads (used in heart devices for pacing and defibrillation) due to reports of difficulty achieving proper fixation during implantation. This implantation difficulty could potentially cause tissue trauma during the surgical procedure.
- If you have received this lead, contact your cardiologist or the implanting hospital to discuss your specific situation.
- Do not attempt to remove or replace the device yourself; work with your medical team.
- Ask your doctor whether your lead's serial number is affected by checking the FDA recall notice.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
717
Manufactured in
8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2027Want us to check the next one for you?
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