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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 FirmOctober 19, 2023
Date PostedNovember 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0354-2024
Recall Event ID 93303
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductModel 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Code Information UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactJeffrey Trauring
612-616-9628
Manufacturer Reason
for Recall		Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionMedtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023. The notice explained the issue, potential risk to the patient, and requested the return of the units.
Quantity in Commerce26 units
DistributionInternational distribution to the countries of S. Korea and Turkey.
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.
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