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Open, Classified

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

FDA Recall Z-0354-2024 · Posted 2023-11-20

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2023-10-19
Product Quantity26 units

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.

Firm Action

Medtronic 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

International distribution to the countries of S. Korea and Turkey.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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