Model 97745 Controller used with recall
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Why was Model 97745 Controller used with recalled?
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N
- Product
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 26 units
- Distribution
- International distribution to the countries of S. Korea and Turkey.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)