FDA recall Z-1691-2024
Medtronic Neuromodulation · Class II · device
Product
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Reason for recall
inability to reprogram one device
Distribution
International distribution in the country of UK.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-03-28
- Report date
- 2024-05-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2024