Medtronic Neuromodulation: Device Recall

Recall Details

Recall Number

Z-1543-2025

Classification

Class II

Product Type

Device

Recalling Firm

Medtronic Neuromodulation

Status

Ongoing

Date Initiated

03/04/2025

Location

Minneapolis, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1493 devices

Reason for Recall

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

Product Description

Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

Distribution Pattern

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, 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.

Other Recalls by Medtronic Neuromodulation

• Class II: Risk 12/03/2025
  Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
• Class II: Risk 11/20/2025
  Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
• Class II: Risk 04/03/2025
  Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
• Class II: Risk 01/09/2025
  Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
• Class II: Risk 11/21/2024
  Software issues were identified in application version 2.x.

View all recalls by Medtronic Neuromodulation →