Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a functional defect (inability to reprogram) affecting spinal cord stimulation therapy. While no injuries or illnesses have been reported, a stimulator that cannot be reprogrammed represents a risk-of-harm scenario where therapy parameters cannot be properly adjusted.
Plain-English summary
Medtronic Neuromodulation is recalling the Intellis AdaptiveStim Product Number 97715 spinal cord stimulator. This device delivers electrical stimulation to the spinal cord to help manage chronic pain.
The recall was initiated because of an inability to reprogram one device. This functional defect means the affected device cannot be adjusted or reprogrammed as needed for patient therapy.
This device was distributed internationally in the United Kingdom. Patients who have received this device should contact their healthcare provider for further information and guidance.
Anyone with this device should speak with their doctor or healthcare provider immediately regarding options, including device evaluation or replacement if necessary.
The recalled product
- Product
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 00643169781719
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Similar recalls
- ModerateMedtronic Intellis Spinal Cord Stimulator Software Recall
FDA (Devices) · 2021-01-20
- HighMedtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Stimulation Issues
FDA (Devices) · 2013-11-06
- HighMedtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation
FDA (Devices) · 2013-11-20
- HighVanta INS Neurostimulator May Fail to Communicate with Programmer Systems
FDA (Devices) · 2022-06-01
- HighMedtronic Intellis Clinician Programmer Application Software Malfunction Prevents Parameter Adjustment
FDA (Devices) · 2024-01-31
- ModerateMedtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies
FDA (Devices) · 2016-03-02