Medtronic Neuromodulation: Recalls

100 recall records from Nov 9, 2012 to Sep 8, 2026, newest first. Showing 1 to 100.

What this list covers: FDA records filed under the name "Medtronic Neuromodulation".

Back to the Medtronic Neuromodulation profile

NumberClassProductDate
Z-0267-2027Class IIInterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO…Sep 8, 2026
Z-0266-2027Class IIInterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128…Sep 8, 2026
Z-2241-2026Class IIMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical…May 13, 2026
Z-2240-2026Class IIMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical…May 13, 2026
Z-2201-2026Class IIMedtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on…Apr 8, 2026
Z-1043-2026Class IIA71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product…Dec 3, 2025
Z-0996-2026Class IIRestore Clinician Programmer Application (CP App), Model A71100 used with the following programmers…Nov 20, 2025
Z-1704-2025Class IIEnhanced Verify Evaluation Handset (CFN HH90130FA)Apr 3, 2025
Z-1543-2025Class IIStimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model…Mar 4, 2025
Z-1506-2025Class IIA820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.Jan 9, 2025
Z-0774-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E…Nov 21, 2024
Z-0773-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D…Nov 21, 2024
Z-0772-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C…Nov 21, 2024
Z-0771-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B…Nov 21, 2024
Z-0206-2025Class IIMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.Sep 24, 2024
Z-0372-2025Class IIMedtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A…Sep 18, 2024
Z-0137-2025Class IISynchroMed II Infusion Pump. Product Number: 8637-20Sep 11, 2024
Z-0132-2025Class IIVanta Implantable Neurostimulator (INS), Model 977006Aug 21, 2024
Z-3073-2024Class IIMedtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator…Jun 17, 2024
Z-2427-2024Class IIA610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x…May 15, 2024
Z-2352-2024Class IIMedtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784…May 10, 2024
Z-1691-2024Class IIIntellis AdaptiveStim Product Number 97715, Spinal Cord StimulatorMar 28, 2024
Z-0780-2024Class IIModel A710 Intellis Clinician Programmer Application, version 2.0.97Dec 19, 2023
Z-0615-2024Class IIMedtronic SynchroMed II, Model 8637-40, Programmable pumpNov 13, 2023
Z-0614-2024Class IIMedtronic SynchroMed II, Model 8637-20, Programmable pumpNov 13, 2023
Z-0354-2024Class IIModel 97745 Controller used with Models 97715 and 97716 Intellis NeurostimulatorsOct 19, 2023
Z-2365-2023Class IIMedtronic InterStim Ground Pad REF 041826Jul 6, 2023
Z-2226-2023Class IIA901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer…Jun 21, 2023
Z-2036-2023Class IIVanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulationJun 6, 2023
Z-1408-2023Class IIMedtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist…Mar 17, 2023
Z-0121-2024Class IISenSight Connector Plug, Model Number B31061.Jan 20, 2023
Z-0915-2023Class IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model…Dec 3, 2022
Z-0914-2023Class IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model…Dec 3, 2022
Z-0913-2023Class IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model…Dec 3, 2022
Z-0912-2023Class IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model…Dec 3, 2022
Z-0911-2023Class IIVanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model…Dec 3, 2022
Z-1574-2022Class IIVanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006…Jul 26, 2022
Z-1571-2022Class IIVanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006…Jul 26, 2022
Z-0217-2024Class IILEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.May 27, 2022
Z-1129-2022Class IIPercept PC BrainSense Implantable Neurostimulator (INS) Model B35200Mar 30, 2022
Z-1128-2022Class IIPercept BrainSense Implantable Neurostimulator (INS), Model B35200Mar 30, 2022
Z-1123-2022Class IIVanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology…Mar 30, 2022
Z-0998-2022Class IIMEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset…Feb 28, 2022
Z-0295-2022Class IIMedtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the…Nov 4, 2021
Z-0294-2022Class IIMedtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC…Nov 4, 2021
Z-0293-2022Class IIMedtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim…Nov 4, 2021
Z-0418-2022Class IIModel B35200 - Percept PC BrainSense Implantable NeurostimulatorOct 19, 2021
Z-0201-2022Class IIClinician Programmer Application (CPA) model A610 Clinician Software ApplicationSep 23, 2021
Z-2159-2021Class IIMedtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290Jul 9, 2021
Z-2228-2021Class IIMedtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e)…Jun 2, 2021
Z-1535-2021Class IIIntellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic…Mar 25, 2021
Z-1368-2021Class IIA610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept…Mar 9, 2021
Z-0612-2021Class IIPercept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation…Nov 19, 2020
Z-0860-2021Class IIMedtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application…Nov 12, 2020
Z-2657-2023Class IIRestore Clinician Programmer Application Software, model number A71100, used with the Restore…Jul 17, 2020
Z-0508-2020Class ISynchromed II programmable pump, Model numbers 8637-20 and 8637-40Oct 11, 2019
Z-1774-2019Class IIInterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product…May 15, 2019
Z-2432-2018Class IIVectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175…May 25, 2018
Z-2431-2018Class IIVectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260…May 25, 2018
Z-0537-2018Class IIIMedtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027…Sep 21, 2017
Z-0896-2018Class IIMedtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter…Aug 9, 2017
Z-3069-2017Class IIDBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models…Mar 17, 2017
Z-1694-2017Class IISynchroMed II implantable drug infusion pump, Model 8637-40,Feb 9, 2017
Z-0788-2017Class IMedtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870…Oct 3, 2016
Z-0700-2017Class IIModel 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to…Oct 3, 2016
Z-2645-2016Class IIDBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4)…Jun 23, 2016
Z-2602-2016Class IIMedtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n…Jun 10, 2016
Z-1926-2016Class IIMedtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable…May 3, 2016
Z-1271-2016Class IIMedtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.Feb 9, 2016
Z-0859-2016Class IISpecify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads…Jan 11, 2016
Z-1617-2015Class IIMedtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. SterileApr 16, 2015
Z-1681-2015Class IIMedtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product…Apr 10, 2015
Z-1147-2015Class IIThe Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use…Jan 9, 2015
Z-2259-2014Class IIMedtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx…Jul 14, 2014
Z-2172-2014Class IIMedtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump…Jul 11, 2014
Z-2118-2014Class IIMedtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction…Jun 11, 2014
Z-1723-2014Class IIMedtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda…May 2, 2014
Z-1568-2014Class IIRefill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable…Apr 4, 2014
Z-1526-2014Class IIMedtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external…Feb 27, 2014
Z-1525-2014Class IIMedtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S…Feb 27, 2014
Z-1524-2014Class IIMedtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI…Feb 27, 2014
Z-1570-2014Class IIMedtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable…Feb 26, 2014
Z-0279-2014Class IIMedtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603…Sep 30, 2013
Z-0278-2014Class IIMedtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable…Sep 30, 2013
Z-0125-2014Class IIMedtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable…Sep 30, 2013
Z-0124-2014Class IIMedtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable…Sep 30, 2013
Z-1580-2013Class IMedtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL…Jun 3, 2013
Z-1579-2013Class IMedtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir…Jun 3, 2013
Z-1576-2013Class IMedtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length…Jun 3, 2013
Z-1575-2013Class IMedtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length…Jun 3, 2013
Z-1574-2013Class IMedtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump…Jun 3, 2013
Z-1573-2013Class IMedtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with…Jun 3, 2013
Z-1571-2013Class IMedtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL…Jun 3, 2013
Z-1570-2013Class IMedtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir…Jun 3, 2013
Z-1031-2013Class IIMedtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of…Feb 27, 2013
Z-1191-2013Class IMedtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and…Feb 8, 2013
Z-1190-2013Class IMedtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S…Feb 8, 2013
Z-0567-2013Class IIMedtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only…Dec 3, 2012
Z-0497-2013Class IMedtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml…Nov 9, 2012
Z-0496-2013Class ISynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18…Nov 9, 2012

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.