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

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Neurostimulator Programmer
Hazard
  • device-communication-failure
  • software-defect

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