FDAFDA · Food and drugs·Recall number Z-1691-2024
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Published May 8, 2024 · Recall initiated: March 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
inability to reprogram one device
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- International distribution in the country of UK.
- Lot
- UDI/DI 00643169781719
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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