The Recall Desk
HighFDA (Devices)·Z-1543-2025·Announced 2025-04-16

Medtronic neurostimulator programmer software issue disables implant communication

The Stimulation RC Clinician Programmer Application (Model A71400) has a software issue that can permanently disable communication with implanted neurostimulators when a specific intraoperative programming sequence is used.

What this means for you

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: FDA Class II software defect in a medical device programmer can permanently disable communication with implanted neurostimulators. This is a risk-of-harm product where injury has not been reported in the source, matching the rubric criterion for Score 3 (High severity).

Plain-English summary

The Stimulation RC Clinician Programmer Application Model A71400, manufactured by Medtronic Neuromodulation, is software used to program implanted neurostimulator devices including the Inceptiv (Model 977119) and Intellis Pro (Model 977118).

A software issue in the programmer can permanently disable communication with the implanted neurostimulator when a specific intraoperative programming sequence is used during surgery. Once this communication is disabled, it cannot be recovered, and the programmer can no longer adjust or monitor the implanted device.

Approximately 1,493 units have been distributed worldwide to healthcare facilities in the United States and internationally. The issue only occurs when the specific programming sequence is used during the implant procedure. Medtronic Neuromodulation is notifying healthcare providers to avoid using this sequence.

Patients with these devices should consult their healthcare provider with any questions or concerns about their implanted neurostimulator.

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
Category
Medical Device — Implantable Neurostimulator Programmer
Hazard
  • software-defect
  • communication-failure

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 category