Medtronic Neuromodulation Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
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
Products Sold
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
Medtronic Neuromodulation is recalling Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators due to Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Recommended Action
Per FDA guidance
Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023. The notice explained the issue, potential risk to the patient, and requested the return of the units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026