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Recall Observatory FDA recall evidence

Device product

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

Z-2159-2021

July 09, 2021

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 88272
Status
Ongoing
Classification
Class II
Quantity
1131 units
Official record key
device-enforcement:Z-2159-2021

Official wording

Reason: 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.

Code information: a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.