Medtronic Neuromodulation: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
- Recalling firm
- Medtronic Neuromodulation
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f8e5bf8a-d5ac-48b0-97ef-dd03deffd919