Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
FDA device recall Z-0354-2024 · posted 2023-11-20 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- LGW
- Quantity affected
- 26 units
- Distribution
- International distribution to the countries of S. Korea and Turkey.
- Date initiated
- 2023-10-19
- Date posted
- 2023-11-20
- Location
- Minneapolis, MN
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