Stimulation RC Clinician Programmer Application Software Communication Issue
The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with certain implantable neurostimulators when a specific intraoperative programming sequence is used. Approximately 1,493 devices were distributed worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II and it involves a medical device with potential loss of critical communication function with an implanted neurostimulator, which could require patient intervention or re-intervention. This meets the Severe criterion for Class II with risk of harm to function.
Plain-English summary
Medtronic Neuromodulation is recalling the Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators. A software issue can permanently disable communication with the implantable neurostimulator when a specific intraoperative programming sequence is used.
The recalled units were distributed worldwide to the US (Nationwide) and to countries including Austria, Belgium, Bulgaria, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected patients and healthcare providers should contact Medtronic Neuromodulation for guidance. Serial numbers and UDI-DI information are available in FDA records for identification of affected devices. Patients who have received implants using this device should consult their medical provider regarding potential remediation.
The recalled product
- Product
- Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1,493
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: 00763000371463
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 2x4 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
Similar recalls
- HighMedtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer
FDA (Devices) · 2024-10-30
- ModerateMedtronic Restore Clinician Programmer software recalled for compatibility issue
FDA (Devices) · 2023-10-11
- ModerateMedtronic Intellis Spinal Cord Stimulator Software Recall
FDA (Devices) · 2021-01-20
- HighMedtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems
FDA (Devices) · 2022-06-01
- HighMedtronic Intellis Clinician Programmer Application Software Malfunction Prevents Parameter Adjustment
FDA (Devices) · 2024-01-31
- HighVanta INS Neurostimulator May Fail to Communicate with Programmer Systems
FDA (Devices) · 2022-06-01