Intellis AdaptiveStim Product Number 97715, Spinal Cord… recallZ-1691-2024 · Medtronic Neuromodulation · initiated Mar 28, 2024
Class II Open, Classified All recalls posted in April 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
inability to reprogram one device
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1691-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 28, 2024
- Posted by the FDA
- Apr 26, 2024
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 unit
- Product code
- LGW
- FDA submissions
- P840001
- Distribution
- International distribution in the country of UK.
Product description
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Code information (models, lots, serial numbers)
UDI/DI 00643169781719
Other devices under the same FDA submission
116 devices cleared under P840001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- RestoreSensor 37714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death4,116 reports
- PrimeAdvanced® SureScan® 97702Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death2,263 reports
- RestoreUltra® SureScan® 97712Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,887 reports
- Inceptiv™ 977119Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief1,339 reports
- Vanta™ AdaptiveStim™ 977006Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief3 recalls1,151 reports
- Intellis™ 97716Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy1,125 reports
- Intellis™ 97716Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy635 reports
- RestoreAdvanced® SureScan® 97713Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF632 reports
- Inceptiv™ 977119Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief513 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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