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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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 Class 2 Device Recall Medtronicsee related information
Date Initiated by FirmJanuary 20, 2023
Date PostedOctober 18, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0121-2024
Recall Event ID 93083
PMA NumberP960009S391 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
ProductSenSight Connector Plug, Model Number B31061.
Code Information GTIN 00763000426576, Lot Number 082U30721
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactMedtronic Customer Service
800-962-9888
Manufacturer Reason
for Recall		Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
FDA Determined
Cause 2		Labeling Change Control
ActionMedtronic issued a MEDICAL DEVICE REMOVAL notice to its consignees on 01/20/2023 by mail. Consignees were asked to return any affected product they may have, and to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.
Quantity in Commerce65 devices
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MHY
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