The Recall Desk

Manufacturer

Medtronic Neuromodulation

47 recalls in our database name Medtronic Neuromodulation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 47

  • HighFDA (Devices)·Z-2201-2026·2026-05-20

    Medtronic SynchroMed Flex Infusion Programmer Software Application

    Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.

    Product
    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-0996-2026·2025-12-31

    Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:

    Pending LLM rewrite. Source: FDA_DEVICE Z-0996-2026.

    Product
    Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2025·2025-05-07

    Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator

    Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.

    Product
    Enhanced Verify Evaluation Handset (CFN HH90130FA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1543-2025·2025-04-16

    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.

    Product
    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2025·2025-04-09

    Medtronic A820 myPTM Infusion Pump Software Shows Delayed Patient Response

    Medtronic is recalling the A820 myPTM Software Application used with SynchroMed infusion pumps because the app is taking longer than expected to respond to patient interactions. Approximately 4365 units are affected worldwide.

    Product
    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2025·2025-01-08

    Medtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects

    Medtronic is recalling SynchroMed II and III implantable pumps used with a clinician tablet app that has software issues in version 2.x. Approximately 319 systems were distributed worldwide.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2025·2024-10-30

    Medtronic Percept RC Implantable Neurostimulators Unable to Communicate with Programmer

    Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.

    Product
    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0137-2025·2024-10-30

    SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption

    Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.

    Product
    SynchroMed II Infusion Pump. Product Number: 8637-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2024·2024-07-31

    Medtronic A610 Clinician Programmer pocket adaptors limited to head-only MRI

    Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.

    Product
    A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descripti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2024·2024-07-24

    Medtronic Ascenda Intrathecal Catheter design update to prevent occlusion

    Medtronic is updating the design of its Ascenda Intrathecal Catheter (Models 8780, 8781, 8784) to reduce potential tissue growth into the catheter connector that may cause occlusion. Approximately 111,762 units were distributed worldwide.

    Product
    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2024·2024-05-08

    Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram

    Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.

    Product
    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0614-2024·2024-01-03

    Medtronic SynchroMed II Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.

    Product
    Medtronic SynchroMed II, Model 8637-20, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0615-2024·2024-01-03

    Medtronic SynchroMed II Programmable Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.

    Product
    Medtronic SynchroMed II, Model 8637-40, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0217-2024·2023-11-08

    DBS Lead Device Recall: Use By Date Label Discrepancy

    Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.

    Product
    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0121-2024·2023-10-25

    SenSight Connector Plug Recalled for Use By Date Label Discrepancy

    Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.

    Product
    SenSight Connector Plug, Model Number B31061.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2023·2023-10-11

    Medtronic Restore Clinician Programmer software recalled for compatibility issue

    Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.

    Product
    Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide