Lead Fracture Risk Prompts Medtronic OmniaSecure MRI SureScan Recall 2026

A weak adhesive bond inside certain cardiac leads could give way during implantation, leaving the lead open to fracture over time. Medtronic Inc. has recalled two models of its OmniaSecure MRI SureScan lead in Canada. Health Canada published the notice on September 23, 2026.

The recall is classified as Type II and carries identification number RA-82665. The notice lists the recall date as September 17, 2026. It is addressed to a healthcare audience rather than to the general public.

Recalled Products at a Glance

• Product: OmniaSecure MRI SureScan
• Models: 3930M79 and 3930M74
• Lot or serial numbers: More than 10 numbers are affected, and Health Canada directs readers to the manufacturer for the full list
• Manufacturer: Medtronic Inc., Minneapolis, Minnesota, United States
• Recall class: Type II
• Reference number: RA-82665

Which Items Are Involved?

The recall covers the model 3930M lead in two catalogue configurations, 3930M79 and 3930M74. According to Health Canada, the 3930M is a transvenous DF4 lead labelled for use in the right ventricle and the left bundle branch area.

The lead has a fixed helix design, which means the whole lead must be rotated to fix it in place. Its construction carries torque from the connector and lead body to the distal tip. This supports deep septal placement.

The published notice does not give the number of units affected. It also does not list individual lot or serial numbers. It says there are more than ten numbers and that the manufacturer should be contacted for them.

What Triggered the Recall

To support the lead’s function, the design uses interlocking mechanical features between the helix and the tip-to-ring spacer. An adhesive bond applied during manufacturing adds to that connection. The adhesive is dispensed manually in a three-step process.

Health Canada says analysis of returned product, along with some early returns, showed inadequate adhesive coverage at the interface between the tip-to-ring spacer and the helix. The current investigation points to operator technique and inspection as contributing to the root cause.

Insufficient adhesive at the interface between the driveshaft assembly and the spacer produces a weak bond. Torque applied during the implant procedure may then break that bond.

Why This Matters

If the bond breaks, the helix can separate from the spacer. The notice calls this driveshaft separation. The overall lead connection with the cable can be maintained even when separation occurs.

If separation occurs and the lead is implanted, the helix and cable assembly are left unsupported. In that situation, lead fracture may occur over time. The notice does not describe specific patient outcomes or report any injuries.

Who Should Be Concerned

Health Canada lists Canada as the affected location and healthcare as the audience. The notice is therefore most relevant to hospitals, implanting physicians and cardiac device teams. It is also relevant to anyone involved in handling or implanting the listed models.

The notice does not say where the products were distributed within Canada. It does not name any retailers or facilities.

Patients who have questions about a cardiac lead that has been implanted should raise them with their own healthcare provider. The Health Canada notice does not give patient-specific instructions.

What Consumers Need to Do Now

The action listed by Health Canada is brief. Contact the manufacturer if you need additional information. Because the lot and serial numbers are not printed in the public notice, healthcare facilities should request the full list of affected numbers from Medtronic to check inventory against models 3930M79 and 3930M74.

Health Canada also gives a public route for reporting health or safety concerns. It runs a subscription service for email updates about new and updated recalls and safety alerts.

Regulatory Response

The recall was published by Health Canada under its medical devices program, in the cardiovascular category. The issue is listed as a medical device performance problem. Health Canada last updated the notice on September 23, 2026.

The notice names Medtronic Inc. as the company and gives its address as 710 Medtronic Parkway N.E., Minneapolis, Minnesota. It does not include a company statement, a customer service number or a refund process. Readers who need those details should contact the manufacturer directly.

As of the notice date, the investigation into the manual adhesive process was still described as current. Further updates to RA-82665 may appear on the Health Canada recalls and safety alerts site.