Reported Nov 29, 2023 · Ongoing
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Lot codes and dates
- UDI/DI 00763000642297
- Serial Numbers
NLD172060NNLD142952NNLD172064NNLD142947NNLD142942NNLD172061NNLD172062NNLD172063NNLD172066NUDI/DI 00763000724436
- Serial Numbers
NLD160337NNLD163006NNLD142943NNLD163007NNLD142944NNLD163008NNLD160338NNLD163009NNLD160339NNLD163010NNLD160340NNLD163011N
- Amount recalled
- 26 units
Why it was recalled
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
This product could cause temporary or reversible health problems — stop using it.
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