Recall Z-0266-2027— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2026-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-08
- Firm location
- Minneapolis, MN, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.