Quick summary
Quick summary: InterStim™ Systems. Reason: Health product recall. Category: Health products. Date: 2026-09-24.
Public recall detail
InterStim™ Systems
2026-09-24
Health products
Health product recall
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: InterStim™ Systems. Reason: Health product recall. Category: Health products. Date: 2026-09-24.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandMEDTRONIC INC.
ProductInterStim™ Systems
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-82674
Affected products
ProductInterStim™ Percutaneous Extension
LotMore than 10 numbers, contact manufacturer.
Model3560030
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ Percutaneous Extension
ProductInterStim™ Percutaneous Extension
LotMore than 10 numbers, contact manufacturer.
Model3560022
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ Percutaneous Extension
ProductInterStim™ SureScan™ MRI Lead Kit
LotMore than 10 numbers, contact manufacturer.
Model978B133
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ SureScan™ MRI Lead Kit
ProductInterStim™ SureScan™ MRI Lead Kit
LotMore than 10 numbers, contact manufacturer.
Model978B141
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ SureScan™ MRI Lead Kit
ProductInterStim™ SureScan™ MRI Lead Kit
LotMore than 10 numbers, contact manufacturer.
Model978A128
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ SureScan™ MRI Lead Kit
ProductInterStim™ SureScan™ MRI Lead Kit
LotMore than 10 numbers, contact manufacturer.
Model978A133
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ SureScan™ MRI Lead Kit
ProductInterStim™ SureScan™ MRI Lead Kit
LotMore than 10 numbers, contact manufacturer.
Model978B128
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionInterStim™ SureScan™ MRI Lead Kit
Issue
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.
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Recall date2026-09-15
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82674
Background{}
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
AudiencesHealthcare
Source updated2026-09-24
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
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Product images
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