The Recall Desk

Manufacturer

Medtronic Neuromodulation

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

What the numbers show

Total
98
Critical
1
Severe
5
Most recent
2026-06-03

Of the 98 recalls from Medtronic Neuromodulation we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) are Severe.

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.

51–75 of 98

  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2021·2021-01-20

    Medtronic Intellis Spinal Cord Stimulator Software Recall

    Medtronic is recalling the Intellis Spinal Cord Stimulator software due to a defect that prevents clinicians from programming the implantable neurostimulation device.

    Product
    Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2021·2020-12-23

    Medtronic Percept PC Neurostimulator Recall Due to Software Connection Failure

    Medtronic is recalling 12 Percept PC Implantable Neurostimulators because a software anomaly in the A620 Patient Programmer prevents connection to the device.

    Product
    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2020·2019-12-11

    Medtronic Synchromed II Pumps Recalled for Potential Motor Stall

    Medtronic is recalling Synchromed II programmable pumps due to a potential foreign particle that could cause a permanent motor stall.

    Product
    Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1774-2019·2019-06-19

    Medtronic InterStim System Recall for Unexpected Stimulation Increase

    Medtronic is recalling InterStim System kits due to a potential for unexpected stimulation increases during programming with the A10 Clinician Application.

    Product
    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2018·2018-07-25

    Medtronic Vectris MRI Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Sure Scan MRI Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional co
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2431-2018·2018-07-25

    Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurost
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0896-2018·2018-03-14

    Medtronic Recalls Unimplanted SynchroMed II Pumps Due to Motor Stall Risk

    Medtronic is recalling unimplanted SynchroMed II Model 8637 pumps to address a design flaw that can cause motor stalls due to corrosion.

    Product
    Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0537-2018·2018-02-14

    Medtronic Ascenda Intrathecal Catheter Recall for Kinking Risk

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters due to a potential risk of kinking at the proximal end where the catheter connects to the drug infusion pump.

    Product
    Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3069-2017·2017-08-30

    Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect

    Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.

    Product
    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead h
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-1694-2017·2017-04-05

    Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

    Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

    Product
    SynchroMed II implantable drug infusion pump, Model 8637-40,
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0788-2017·2017-03-08

    Medtronic SynchroMed II Software Card Recall for Priming Bolus Function

    Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.

    Product
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2017·2016-12-14

    Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation

    Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.

    Product
    Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2016·2016-08-31

    Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage

    Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.

    Product
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2645-2016·2016-08-31

    Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk

    Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.

    Product
    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimula
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1926-2016·2016-06-15

    Medtronic RestoreSensor Implantable Neurostimulators Recalled for Battery Depletion

    Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.

    Product
    Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1271-2016·2016-04-06

    Medtronic Ascenda Intrathecal Catheter Kit Recalled for Labeling Errors

    Medtronic is voluntarily removing a single Ascenda Intrathecal Catheter kit due to incorrect outer package labels that may result in missing components.

    Product
    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0859-2016·2016-03-02

    Medtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies

    Medtronic is recalling Specify 5-6-5 and 2x8 spinal cord stimulation leads because the labeling does not adequately distinguish between permanent implant and trialing use.

    Product
    Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2015·2015-06-03

    Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure

    Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.

    Product
    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2015·2015-03-04

    Medtronic Neurostimulator Recall Due to Inaccurate Battery Longevity Estimates

    Medtronic is recalling specific neurostimulator models because enabling cycling at certain settings may decrease battery life and cause inaccurate longevity estimates on the programmer.

    Product
    The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2014·2014-08-27

    Medtronic Recalls Six Activa PC Implantable Neurostimulators

    Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

    Product
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2172-2014·2014-08-20

    Medtronic Recalls Ascenda Intrathecal Catheters Due to Retainer Ring Defect

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.

    Product
    Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2014·2014-08-06

    Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment

    Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.

    Product
    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtro
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1723-2014·2014-06-11

    Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination

    Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.

    Product
    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtroni
    Category
    Medical Device
    Distribution
    1 state