Medtronic Intellis AdaptiveStim Spinal Cord Stimulator Recall: Inability to Reprogram One
Medtronic recalls Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 due to inability to reprogram one device. Affected units have UDI/DI 00643169781719.
Lower-risk recall
inability to reprogram one device
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What happened, in plain English
Medtronic is recalling spinal cord stimulators with Product Number 97715 because one device cannot be reprogrammed. This could prevent necessary adjustments to the device's settings. Read more at govinfonow.com/recall/55692-medtronic-intellis-adaptivestim-spinal-cord-stimulator-recall-inability-to-reprogram.
Source Summary by GovInfoNow · govinfonow.com/recall/55692-medtronic-intellis-adaptivestim-spinal-cord-stimulator-recall-inability-to-reprogram · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1691-2024
Cite this page
“Medtronic Intellis AdaptiveStim Spinal Cord Stimulator Recall: Inability to Reprogram One.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55692-medtronic-intellis-adaptivestim-spinal-cord-stimulator-recall-inability-to-reprogram. Based on FDA recall #Z-1691-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2024%22&limit=1).
Why it’s dangerous
The device cannot be reprogrammed, which means adjustments to the stimulation settings may not be possible. This could affect the device's effectiveness for managing pain or other conditions.
Who’s affected
Patients using Medtronic Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 are affected. Those with the specific UDI/DI 00643169781719 are most at risk.
How to tell if you have this one
Check for the Product Number 97715 on the device. Affected units have the UDI/DI code 00643169781719.
- Brand
Medtr: a short, human brand name for headings (e.g.- Category
Medical device
What to do — step by step
Check Device Model
Look for Product Number 97715 and UDI/DI 00643169781719 on the device.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1691-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1691-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.