FDA-Device2021-08-04Class II
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medtronic Neuromodulation
Hazard
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.
Sold states
Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Affected count
1131 units
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2021Don't want to check this manually?
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