Medtronic Intellis Clinician Programmer Application Software Malfunction Prevents Parameter Adjustment
Medtronic is recalling the Intellis A710 Clinician Programmer Application version 2.0.97 because it may fail to communicate with the implanted neurostimulator, preventing clinicians from adjusting patient therapy parameters.
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: Class II medical device recall with no reported injuries. The software defect prevents therapy parameter adjustment, posing a risk of inadequate or excessive stimulation, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Medtronic Intellis A710 Clinician Programmer Application, version 2.0.97 is being recalled. This software application is used by clinicians to program and adjust neurostimulation therapy for patients with implanted Medtronic neurostimulator devices.
A defect in this version of the application can prevent it from establishing a communication session with the implanted neurostimulator. When this communication failure occurs, clinicians cannot adjust the patient's stimulation parameters.
If clinicians cannot adjust stimulation parameters, patients may receive inadequate or excessive stimulation therapy and may not receive optimal pain relief. This defect was identified in a device bearing serial number NPL1000519 in Germany.
The recalled product
- Product
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
- 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 (2)
- UDI/DI 00763000520076
- S/N: NPL1000519
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- 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
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · software defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMedtronic Intellis Spinal Cord Stimulator Software Recall
FDA (Devices) · 2021-01-20
- ModerateMedtronic Restore Clinician Programmer software recalled for compatibility issue
FDA (Devices) · 2023-10-11
- ModerateA901 Communication Manager Software Update Not Available for Intellis System
FDA (Devices) · 2023-08-02
- HighMedtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation
FDA (Devices) · 2021-04-14
- HighVanta Clinician Programmer Application error prevents programming of implanted neurostimulators
FDA (Devices) · 2022-08-31
- HighIntellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
FDA (Devices) · 2024-05-08