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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Vectris SureScan MRI

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  Class 2 Device Recall Medtronic Vectris SureScan MRI see related information
Date Initiated by Firm July 09, 2021
Create Date July 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-2159-2021
Recall Event ID 88272
PMA Number P840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Medtronic Vectris SureScan MRI, Catalog Numbers:
a) 977A260
b) 977A275
c) 977A290
Code Information a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 1131 units
Distribution Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LGW and Original Applicant = MEDTRONIC NEUROMODULATION
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