FDA-Device2026-10-22Class IIMISBRANDING

Medtronic InterStim SureScan MRI Leads recalled for incompatible component selection

LABEL MIX UPNationwide distributionMedical devices

What this means

Medtronic Neuromodulation has recalled certain InterStim SureScan MRI Leads (models 978A1 and 978B1 in lengths 28cm, 33cm, and 41cm) because of an error in component selection. If an incompatible lead or percutaneous extension is used during implantation, the system may not function properly and could require surgical replacement.

If you have one of the affected leads, contact your implanting surgeon or Medtronic immediately to verify which components are in your system.
Do not undergo surgery or replacement procedures until your specific lead and extensions have been confirmed as compatible.
Refer to the lot numbers listed in the recall notice to determine if your device is affected.

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The agency's original wording

Hazard

Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.

Affected count

94,441 (US); 60,488 (OUS)

Manufactured in

7000 Central Ave Ne, Minneapolis, Minnesota, United States

Products

InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II 33CM SSMRI TINED 978B133 LEAD 978B141 ISTM II 41CM SSMRI TINED 978B141

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0266-2027

More Medtronic recalls

FDA-Device2026-10-22
Medtronic InterStim Percutaneous Extensions recalled for incompatibility risk

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