Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
This recall is currently active, issued April 26, 2024. It was issued by Medtronic Neuromodulation.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 28, 2024
- Posted
- April 26, 2024
- Recall Number
- Z-1691-2024
- Quantity
- 1 unit
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
inability to reprogram one device
Distribution
International distribution in the country of UK.
Lot / Code Info
UDI/DI 00643169781719
Root Cause
Under Investigation by firm
Action Taken
Medtronic issued an URGENT FIELD SAFETY NOTICE to its sole consignee on 03/28/2024 via via an in-person delivery of the customer letter by the Technical Services Representative. The notice explained the issue and risk of resetting the device. Also included were trouble shooting steps and a factory reset to be initiated by Medtronic upon the implanting physicians' authorization.
More recalls by Medtronic Neuromodulation
A71200 Vanta" Clinician Programmer Application (CP App) version
2.0.2465 and 2.0.2683, Product numbe...
Jan 9, 2026
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:...
Dec 23, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Apr 30, 2025