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Medtronic Neuromodulation Recall 88272

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

Medtronic Neuromodulation Recall 88272 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2159-2021
Event ID88272
Event DescriptionMedtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Product TypeDevices
DistributionAustria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Quantity1131 units
Recall ReasonSpecific 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.
Device Classification20210804
Device Code Infoa) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Center Classification Date20210728
Recall Initiation Date20210709
Recalling FirmMedtronic Neuromodulation
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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