—#188265

Product

Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001
Affected lot / code info: a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

Why it was recalled

Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

Root cause (FDA determination)

Error in labeling

Action the firm took

The firm initiated the recall on 07/07/2021 by regionally approve method (e.g. courier, registered mail, hand delivery). The firm is requesting the return of the devices.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Timeline

Recall initiated: 2021-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.