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Class 2 Device Recall Stimulator, electrical, implantable device. |
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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
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Product |
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
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Code Information |
UDI/DI 00763000274320, Serial Number VA2JV2V
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Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 7000 Central Ave Ne Minneapolis MN 55432-3568
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For Additional Information Contact |
Medtronic Customer Service 800-962-9888
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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.
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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
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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.
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PMA Database |
PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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