Medtronic OmniaSecure Model 3930M Ventricular Lead Recall for Fixation Issues
Medtronic is recalling 717 OmniaSecure Model 3930M ventricular leads due to complaints about difficulty achieving fixation during implantation, which poses a potential risk of tissue trauma.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source identifies a potential hazard of tissue trauma due to implant difficulty. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic, Inc. is recalling 717 units of the OmniaSecure Model 3930M ventricular lead. The affected products include specific serial numbers for the 3930M74 and 3930M79 models. These leads are designed for pacing, sensing, cardioversion, and defibrillation therapies.
The recall is being conducted because of complaints regarding difficulty in achieving fixation during implantation. The FDA classifies this as a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. The potential harm identified is tissue trauma due to the implant difficulty.
The affected leads were distributed nationwide in the United States and in several international countries, including Australia, Canada, and various European nations. The source text does not report any illnesses, injuries, or deaths associated with this recall. Healthcare providers should contact Medtronic for instructions on evaluating and managing the affected devices.
The recalled product
- 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…
- Manufacturer
- Medtronic, Inc.
- Category
- Medical Device — Cardiac Lead
- Affected units
- 717
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 3930M74 UDI-DI 00763000643430
- 00763000643447
- 00763000759919
- 00763000643461
Distribution
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