InterStim™ Systems Recall Over Incompatible Component Selection
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 has issued a recall for certain InterStim Percutaneous Extensions and SureScan MRI Lead Kits after 15 complaints of incompatible component use between 2020 and 2026.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on September 24, 2026 and geographically references Canada. Its severity classification of "medium" 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.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, health-canada, medical-devices.
What Happened
Medtronic has received 15 complaints involving the selection of an incompatible component based on the intended system configuration between 01-Jan-2020 through 12-Aug-2026. Use of an incompatible lead or percutaneous extension has resulted in a delay of surgery or the need for surgical replacement of the component. Review of complaint data confirmed that the product is functioning as designed and there are no device or product performance issues.
Which Products Are Affected
The following products are affected:
- InterStim™ Percutaneous Extension, model 3560030
- InterStim™ Percutaneous Extension, model 3560022
- InterStim™ SureScan™ MRI Lead Kit, model 978B133
- InterStim™ SureScan™ MRI Lead Kit, model 978B141
- InterStim™ SureScan™ MRI Lead Kit, model 978A128
- InterStim™ SureScan™ MRI Lead Kit, model 978A133
- InterStim™ SureScan™ MRI Lead Kit, model 978B128
More than 10 lot or serial numbers are affected for each model; contact the manufacturer for details. The recalling firm is Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
What You Should Do
Consumers should contact the manufacturer for additional information regarding affected units.
Why This Matters
The recall addresses reports of surgical delays or component replacements due to incompatible component selection in InterStim systems.
Source
Original source: Health Canada Official Notice ↗
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Elsewhere in the country: similar 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 (1,496 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 24, 2026.
Frequently Asked Questions
Questions readers often have about this Health Canada recall.