PlainRecalls

Medtronic Neuromodulation

Compiled from official public sources by the editorial team.

98 recalls on record · Latest: Jun 3, 2026

Medtronic Neuromodulation Recall Insight

Medtronic Neuromodulation appears on 98 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.096% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 3, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 48 entries, severity tagging shows 14 critical, 33 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 48 of 48 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (48). The date window on this page runs from Dec 19, 2012 to Apr 14, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 14, 2021

A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, ver…

FDA Devices Moderate Jan 20, 2021

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by cli…

FDA Devices Moderate Dec 23, 2020

Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is i…

FDA Devices Critical Dec 11, 2019

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

FDA Devices Moderate Jun 19, 2019

InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician applicatio…

FDA Devices Moderate Jul 25, 2018

Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kit…

FDA Devices Moderate Jul 25, 2018

Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A…

FDA Devices Moderate Mar 14, 2018

Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed…

FDA Devices Low Feb 14, 2018

Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 0…

FDA Devices Moderate Aug 30, 2017

DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit conta…

FDA Devices Moderate Apr 5, 2017

SynchroMed II implantable drug infusion pump, Model 8637-40,

FDA Devices Critical Mar 8, 2017

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician…

FDA Devices Moderate Dec 14, 2016

Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulato…

FDA Devices Moderate Aug 31, 2016

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

FDA Devices Moderate Aug 31, 2016

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 neuro…

FDA Devices Moderate Jun 15, 2016

Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intrac…

FDA Devices Moderate Apr 6, 2016

Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

FDA Devices Moderate Mar 2, 2016

Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating ch…

FDA Devices Moderate Jun 3, 2015

Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II …

FDA Devices Moderate May 27, 2015

Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

FDA Devices Moderate Mar 4, 2015

The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, …

FDA Devices Moderate Aug 27, 2014

Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-ch…

FDA Devices Moderate Aug 20, 2014

Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda…

FDA Devices Moderate Aug 6, 2014

Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System fo…

FDA Devices Moderate Jun 11, 2014

Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system…

FDA Devices Moderate May 14, 2014

Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Ref…

FDA Devices Moderate May 14, 2014

Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are pa…

FDA Devices Moderate May 7, 2014

Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulato…

FDA Devices Moderate May 7, 2014

Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR Sure…

FDA Devices Moderate May 7, 2014

Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software applicat…

FDA Devices Moderate Nov 20, 2013

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

FDA Devices Moderate Nov 20, 2013

Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep…

FDA Devices Moderate Nov 6, 2013

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Med…

FDA Devices Moderate Nov 6, 2013

Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic A…

FDA Devices Critical Jul 3, 2013

Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge …

FDA Devices Critical Jul 3, 2013

Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, conne…

FDA Devices Critical Jul 3, 2013

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump…

FDA Devices Critical Jul 3, 2013

Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spina…

FDA Devices Critical Jul 3, 2013

Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.)…

FDA Devices Critical Jul 3, 2013

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Pro…

FDA Devices Critical Jul 3, 2013

Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle…

FDA Devices Critical Jul 3, 2013

Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.)…

FDA Devices Critical May 8, 2013

Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is …

FDA Devices Critical May 8, 2013

Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The…

FDA Devices Moderate Apr 10, 2013

Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction seco…

FDA Devices Moderate Dec 26, 2012

Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Ric…

FDA Devices Critical Dec 19, 2012

SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an…

FDA Devices Critical Dec 19, 2012

Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pum…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.