Z-1691-2024 Class II Ongoing
FDA device recall Z-1691-2024 was initiated by Medtronic Neuromodulation on Mar 28, 2024 and is designated Class II. Reason for recall: inability to reprogram one device The recall status is ongoing. Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product description
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Reason for recall
inability to reprogram one device
Distribution pattern
International distribution in the country of UK.
Code information
UDI/DI 00643169781719
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1691-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026