CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator recalled
Medtronic Neuromodulation is recalling Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator. The recall was initiated on 28 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1691-2024
- FDA event ID
- 94338
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2024
- FDA classified
- 26 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 28 Mar 2024 | Recall initiated by company | |
| 26 Apr 2024 | Classified by FDA | +29 days |
| 8 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
inability to reprogram one device
Product as listed by the FDA
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Where it was distributed
International distribution in the country of UK.
Questions about this recall
Why was it recalled?
inability to reprogram one device
Which lots are affected?
UDI/DI 00643169781719
Where was it sold?
International distribution in the country of UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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