Medtronic InterStim Leads and Extensions Recalled 2026: Health Canada

Health Canada has published a Type II health product recall covering several Medtronic InterStim™ percutaneous extensions and SureScan™ MRI lead kits, citing a device compatibility issue. The recall, identified as RA-82674, carries a recall date of 2026-09-15 and was posted on the department’s recalls and safety alerts website on 2026-09-24. The notice is aimed at the healthcare audience rather than the general public.

According to the notice, the recall stems from complaints about clinicians selecting an incompatible component for the intended system configuration. Medtronic Inc., the manufacturer, is based in Minneapolis, Minnesota.

Products Affected by This Recall

The recall covers two product types within the InterStim™ Systems family: percutaneous extensions and SureScan™ MRI lead kits. Health Canada lists seven model or catalogue numbers in total.

• InterStim™ Percutaneous Extension: model numbers 3560030 and 3560022
• InterStim™ SureScan™ MRI Lead Kit: model numbers 978B133, 978B141, 978A128, 978A133 and 978B128

For each of these models, the notice states that more than 10 lot or serial numbers are involved. Because the list is too long to publish, Health Canada directs readers to contact the manufacturer for the full set of numbers.

What Triggered the Recall

Medtronic reported receiving 15 complaints between 01-Jan-2020 and 12-Aug-2026. Each involved the selection of an incompatible component based on the intended system configuration. In other words, the wrong lead or percutaneous extension was chosen for the setup being used.

The notice says that use of an incompatible lead or percutaneous extension has resulted in a delay of surgery. In some cases it has led to the need for surgical replacement of the component.

Medtronic’s review of the complaint data found that the products are functioning as designed. The notice states there are no device or product performance issues. The problem, as described, lies in matching components correctly rather than in a fault with the hardware itself.

Who Should Be Concerned

The alert is categorized under gastroenterology and urology medical devices, and it is published for a healthcare audience. That means the people most directly affected are the clinicians and facilities that select and implant InterStim™ system components. Patients scheduled for a procedure that involves these components may also want to be aware that the issue exists.

The recall was posted by Health Canada, and the notice lists Canada as its spatial coverage. The source does not state how many units are affected, and it does not provide a distribution breakdown by province.

How to Respond to This Recall

The only action Health Canada lists is to contact the manufacturer if you require additional information. The notice does not instruct anyone to return products or stop using them, and it does not describe a refund or replacement process.

• Healthcare professionals can contact Medtronic Inc. to obtain the complete list of lot and serial numbers for the affected models.
• Facilities that stock these components can check their inventory against the seven model numbers listed above.
• Patients with questions about their own device or an upcoming procedure can raise them with their healthcare provider.

Anyone who has a health or safety concern related to a product can also report it through Health Canada’s online reporting channel.

Regulatory Response

Health Canada classified the action as a Type II recall. The department’s notice describes the issue as a medical device compatibility problem and states that the recall date was 2026-09-15. The alert type is listed as a health product recall, and the identification number is RA-82674.

The department also invites the public to subscribe to email notifications for new and updated recalls and safety alerts. The notice was last updated on 2026-09-24.

Quick Facts

• Manufacturer: Medtronic Inc.
• Product: InterStim™ Systems
• Issue: Medical devices – device compatibility
• Complaints received: 15 (01-Jan-2020 to 12-Aug-2026)
• Recall class: Type II
• Recall number: RA-82674
• Recall date: 2026-09-15