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.

26–47 of 47

  • ModerateFDA (Devices)·Z-2365-2023·2023-08-16

    Medtronic InterStim Ground Pad Recalled for Incorrect Expiration Date Label

    Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.

    Product
    Medtronic InterStim Ground Pad REF 041826
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2226-2023·2023-08-02

    A901 Communication Manager Software Update Not Available for Intellis System

    The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.

    Product
    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2036-2023·2023-07-05

    Vanta Implantable Neurostimulator May Become Unresponsive During Cardioversion

    Cardioversion procedures can damage electronics in Vanta implantable neurostimulators, making them unresponsive. Medtronic has received two complaints resulting in device removal surgeries.

    Product
    Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1408-2023·2023-04-26

    Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage

    Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.

    Product
    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2023·2023-01-18

    Medtronic Vanta Seqenita LT Neurostimulation Device Recalled for Software Anomalies

    Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0911-2023·2023-01-18

    Neurostimulation Clinician Programmer Software Anomalies Affecting Device Control

    Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0912-2023·2023-01-18

    Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall

    Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0915-2023·2023-01-18

    Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled

    Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0913-2023·2023-01-18

    Medtronic Neurostimulation Programmer Software Errors Affect 18 Devices

    Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1571-2022·2022-08-31

    Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators

    The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.

    Product
    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2022·2022-08-31

    Vanta Clinician Programmer Software Cannot Connect with Multiple Implants

    The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.

    Product
    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1128-2022·2022-06-01

    Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems

    Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.

    Product
    Percept BrainSense Implantable Neurostimulator (INS), Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2022·2022-06-01

    Vanta INS Neurostimulator May Fail to Communicate with Programmer Systems

    Medtronic has recalled certain Vanta INS Implantable Neurostimulator devices that may fail to communicate with clinical or patient programmer systems, preventing proper monitoring and therapy adjustments.

    Product
    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2022·2022-06-01

    Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure

    Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.

    Product
    Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2022·2022-05-04

    Medtronic InterStim Clinician Software Has Data Loss Anomaly Affecting Patient Information

    The InterStim X Clinician software used to program urinary incontinence therapy has a software bug that causes patient information to be lost and display a 'Data Lost' notification.

    Product
    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) Inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2022·2022-01-05

    Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion

    The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.

    Product
    Model B35200 - Percept PC BrainSense Implantable Neurostimulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2022·2021-12-01

    Medtronic Wireless Recharger Model WR9200 Becomes Unresponsive on Improper Use

    Medtronic is recalling the Wireless Recharger Model WR9200 used with RestoreUltra and RestoreSensor neurostimulator implants. The recharger becomes unresponsive if charging instructions from the user guide are not followed correctly.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2022·2021-12-01

    Medtronic Wireless Recharger for InterStim Micro May Become Unresponsive

    Medtronic's wireless recharger for the InterStim Micro implantable neurostimulator may become unresponsive if charging procedures from the user guide are not followed. Approximately 10,081 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2022·2021-12-01

    Medtronic Wireless Recharger for Activa RC May Become Unresponsive

    Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0201-2022·2021-11-10

    Medtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall

    Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.

    Product
    Clinician Programmer Application (CPA) model A610 Clinician Software Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2159-2021·2021-08-04

    Medtronic Vectris SureScan MRI lead kits recalled for incorrect labeling

    Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.

    Product
    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
    Category
    Medical Device
    Distribution
    0 states