Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Model 97745 Controller used with Models 97715 and 97716 Intellis Recalled by Medtronic Neuromodulation Due to Units distributed in Korea and Turkey that did...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.
Affected Products
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Quantity: 26 units
Why Was This Recalled?
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Where Was This Sold?
International distribution to the countries of S. Korea and Turkey.
About Medtronic Neuromodulation
Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report