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U.S. Department of Health and Human Services

Class 2 Device Recall Stimulator, electrical, implantable device.

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  Class 2 Device Recall Stimulator, electrical, implantable device. see related information
Date Initiated by Firm May 27, 2022
Date Posted November 03, 2023
Recall Status1 Completed
Recall Number Z-0217-2024
Recall Event ID 93170
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Code Information UDI/DI 00763000274320, Serial Number VA2JV2V
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer Reason
for Recall		 There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
FDA Determined
Cause 2		 Labeling Change Control
Action Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.
Quantity in Commerce 14 units
Distribution US: MO, FL, TX, WA
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.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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