Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Read the official notice →- Date
- 2023-11-29
- Country
- United States
- Brand
- Medtronic Neuromodulation
- Product
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Classification
- Class II
- Units
- International distribution to the countries of S. Korea and Turkey.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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