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Class 2 Device Recall Medtronic Vectris SureScan MRI |
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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
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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
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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.
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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
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Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LGW and Original Applicant = MEDTRONIC NEUROMODULATION
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