Medtronic Neuromodulation
Minneapolis, MN
This page shows every FDA and USDA recall linked to Medtronic Neuromodulation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
173
Total Recalls
2006
First Recall
2026
Most Recent
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Dec 3, 2019
· Device
Terminated
InterStim(TM) System, Model Numbers:
a) TH90G01
b) TH90GFA
c) TH90G02
d) TH90G03
Product Usage:
The Medtronic...
Jun 7, 2019
· Device
Active
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models:
(a) 977A160
(b) 977A175
(c) 977A190...
Jul 13, 2018
· Device
Terminated
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models:
(a) 977D160
(b) 977D260
Product Usa...
Jul 13, 2018
· Device
Terminated
Medtronic Ascenda(R) Intrathecal Catheter, Models:
(a) 8780, UDI: 00643169202122, 00643169783027
(b) 8781, UD...
Feb 6, 2018
· Device
Terminated
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter.
Product Usage:
T...
Aug 9, 2017
· Device
Active
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/338...
Mar 17, 2017
· Device
Terminated
SynchroMed II implantable drug infusion pump, Model 8637-40,
Feb 9, 2017
· Device
Terminated
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Applicat...
Dec 19, 2016
· Device
Terminated
Model 37751 Recharger
Product Usage:
The Medtronic 37751 Recharger is a hand-held device used to charge the b...
Oct 3, 2016
· Device
Terminated
DBS Pocket Adaptor, Model 64001 and Model 64002.
The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adap...
Jun 23, 2016
· Device
Terminated
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Jun 10, 2016
· Device
Terminated
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimul...
Jun 7, 2016
· Device
Terminated
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Mar 29, 2016
· Device
Terminated
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a...
Jan 11, 2016
· Device
Terminated
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stim...
Jun 26, 2015
· Device
Terminated
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile.
Product Usage:
The...
May 28, 2015
· Device
Terminated
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
May 15, 2015
· Device
Terminated
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only.
The Ac...
Aug 18, 2014
· Device
Terminated
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Rev...
Aug 8, 2014
· Device
Terminated
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000.
For use in conjunction with the Medt...
Jul 25, 2014
· Device
Terminated
Medtronic Model 8780 Ascenda Intrathecal Catheter.
The implantable Medtronic Model 8780 Ascenda Intrathecal C...
Jun 4, 2014
· Device
Terminated
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Inf...
May 8, 2014
· Device
Terminated
Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40.
The implantable Medtronic Syn...
May 8, 2014
· Device
Terminated
Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators whic...
Apr 29, 2014
· Device
Terminated
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Mu...
Apr 29, 2014
· Device
Terminated
Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), Re...
Apr 29, 2014
· Device
Terminated
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulato...
Nov 14, 2013
· Device
Terminated
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-progra...
Nov 14, 2013
· Device
Terminated
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulato...
Oct 31, 2013
· Device
Terminated
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for D...
Oct 31, 2013
· Device
Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) St...
Jun 25, 2013
· Device
Terminated
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supp...
Jun 25, 2013
· Device
Terminated
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supp...
Jun 25, 2013
· Device
Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) S...
Jun 25, 2013
· Device
Terminated
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with at...
Jun 24, 2013
· Device
Terminated
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guid...
Jun 24, 2013
· Device
Terminated
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sut...
Jun 24, 2013
· Device
Terminated
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and g...
Jun 24, 2013
· Device
Terminated
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and...
May 1, 2013
· Device
Terminated
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic.
Prod...
May 1, 2013
· Device
Terminated
Medtronic Prostiva RF Therapy Generator.
The Prostiva RF system is indicated for the treatment of symptoms du...
Apr 2, 2013
· Device
Terminated
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured i...
Dec 19, 2012
· Device
Terminated
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable...
Dec 13, 2012
· Device
Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) St...
Dec 13, 2012
· Device
Terminated
Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The Syste...
Mar 30, 2012
· Device
Terminated
Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactur...
Mar 29, 2010
· Device
Terminated
Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner pa...
Dec 11, 2009
· Device
Terminated
Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neu...
Oct 29, 2009
· Device
Terminated
Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Mi...
Sep 29, 2009
· Device
Terminated