Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Company
- Medtronic Neuromodulation
- Recall Initiated
- October 19, 2023
- Posted
- November 20, 2023
- Recall Number
- Z-0354-2024
- Quantity
- 26 units
- Firm Location
- Minneapolis, MN
Reason for Recall
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Distribution
International distribution to the countries of S. Korea and Turkey.
Lot / Code Info
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
Root Cause
Software Manufacturing/Software Deployment
Action Taken
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.