Recall Z-0354-2024— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2023-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators. Reason: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-19
- Firm location
- Minneapolis, MN, United States
Product description
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.