Medtronic Neuromodulation: Device Recall

Recall #Z-0771-2025 · 11/21/2024

Class II: Risk

Recall Details

Recall Number: Z-0771-2025
Classification: Class II
Product Type: Device
Recalling Firm: Medtronic Neuromodulation
Status: Ongoing
Date Initiated: 11/21/2024
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 319 systems

Reason for Recall

Software issues were identified in application version 2.x.

Product Description

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

Distribution Pattern

Worldwide - US Nationwide distribution.

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 03/04/2025

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

View all recalls by Medtronic Neuromodulation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.