CanadaOmniaSecure™ MRI SureScan™ defibrillation leads (models 3930M79 and 3930M74; affected lot/serial numbers: more than 10 numbers — contact Medtronic) are being recalled after Medtronic identified a subset that may have undergone a specific manufacturing sequence. Five complaints reported difficulty achieving fixation during implant procedures for leads that were not implanted; there have been no reports of patient harm and if an identified lead is implanted no action beyond current standard of care is required. Contact the manufacturer for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: OmniaSecure™ MRI SureScan™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3930M79
Affected products: OmniaSecure™ MRI SureScan™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3930M74
The hazard
Medtronic’s manufacturing quality processes identified a subset of OmniaSecure™ (Model 3930M) defibrillation leads which may have undergone a specific manufacturing sequence that requires these leads to be retrieved for additional engineering evaluation. As of 27 August 2026, Medtronic has received five (5) complaints associated with leads that underwent this specific manufacturing sequence. In each complaint, difficulty achieving fixation was reported during the implant procedure; none of the leads were implanted. There have been zero (0) reports of patient harm. If one of the identified lead(s) in this recall is implanted, there is no further action required beyond current standard of care. Medtronic will provide additional information, if appropriate, based on the ongoing engineering evaluation.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)