Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
FDA device recall Z-1691-2024 · posted 2024-04-26 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- inability to reprogram one device
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LGW
- Quantity affected
- 1 unit
- Distribution
- International distribution in the country of UK.
- Date initiated
- 2024-03-28
- Date posted
- 2024-04-26
- Location
- Minneapolis, MN
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