Recall Z-0354-2024 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
| Date | Nov 20, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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. |
| Quantity | 26 units |
| Distribution | International distribution to the countries of S. Korea and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.