Medtronic OmniaSecure MRI SureScan Recall Over Driveshaft Separation
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Medtronic is recalling certain OmniaSecure MRI SureScan transvenous DF4 leads due to risk of driveshaft separation from inadequate adhesive coverage.
Reading this Health Canada recall beyond the headline
This notice was issued by Health Canada on September 23, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, health-canada, MedicalDevice.
What Happened
The model 3930M OmniaSecure MRI SureScan lead uses a fixed helix design. Insufficient adhesive at the interface between the driveshaft assembly and TR spacer can cause a weak bond. Torque applied during implant may break the bond, allowing the helix to separate from the TR spacer while maintaining lead connection. If implanted, this can leave the helix and cable unsupported, potentially leading to lead fracture over time.
Which Products Are Affected
- OmniaSecure™ MRI SureScan™ model 3930M79
- OmniaSecure™ MRI SureScan™ model 3930M74 More than 10 serial/lot numbers are affected; contact the manufacturer for details. Distributed by Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
What You Should Do
Contact the manufacturer for information on affected units and next steps.
Why This Matters
The potential for lead fracture in an implanted cardiac lead poses a serious risk to device function.
Source
Original source: Health Canada Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,091 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 23, 2026.
What People Ask
Common questions about this Health Canada recall.