Medtronic Neuromodulation recalls
Medtronic Neuromodulation appears in 98 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Applic…
FDA Device · Class II · 2021-04-14 · Medtronic Neuromodulation
Reason: There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of… - Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for…
FDA Device · Class II · 2021-01-20 · Medtronic Neuromodulation
Reason: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. - Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy
FDA Device · Class II · 2020-12-23 · Medtronic Neuromodulation
Reason: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. - Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
FDA Device · Class I · 2019-12-11 · Medtronic Neuromodulation
Reason: There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall. - InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician applicat…
FDA Device · Class II · 2019-06-19 · Medtronic Neuromodulation
Reason: There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer). - Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead…
FDA Device · Class II · 2018-07-25 · Medtronic Neuromodulation
Reason: This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectr… - Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f)…
FDA Device · Class II · 2018-07-25 · Medtronic Neuromodulation
Reason: This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectr… - Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter
FDA Device · Class II · 2018-03-14 · Medtronic Neuromodulation
Reason: Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted. - Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UD…
FDA Device · Class III · 2018-02-14 · Medtronic Neuromodulation
Reason: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump. - DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead…
FDA Device · Class II · 2017-08-30 · Medtronic Neuromodulation
Reason: Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target. - SynchroMed II implantable drug infusion pump, Model 8637-40
FDA Device · Class II · 2017-04-05 · Medtronic Neuromodulation
Reason: Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating t… - Medtronic SynchroMed II Implantable Drug Infusion System
FDA Device · Class I · 2017-03-08 · Medtronic Neuromodulation
Reason: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the Sy… - Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurosti…
FDA Device · Class II · 2016-12-14 · Medtronic Neuromodulation
Reason: Medtronic has identified an increased number of complaints from customers involving reports of Rechargers (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimul… - DBS Pocket Adaptor, Model 64001 and Model 64002
FDA Device · Class II · 2016-08-31 · Medtronic Neuromodulation
Reason: Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling… - Medtronic, Lead Kit for DBS Stimulation
FDA Device · Class II · 2016-08-31 · Medtronic Neuromodulation
Reason: Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potenti… - Medtronic RestoreSensor, Model 37714
FDA Device · Class II · 2016-06-15 · Medtronic Neuromodulation
Reason: Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device d… - Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide
FDA Device · Class II · 2016-04-06 · Medtronic Neuromodulation
Reason: Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a res… - Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286
FDA Device · Class II · 2016-03-02 · Medtronic Neuromodulation
Reason: Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use. - Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40
FDA Device · Class II · 2015-06-03 · Medtronic Neuromodulation
Reason: Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function. - Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086
FDA Device · Class II · 2015-05-27 · Medtronic Neuromodulation
Reason: Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the… - The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervou…
FDA Device · Class II · 2015-03-04 · Medtronic Neuromodulation
Reason: Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, l… - Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only
FDA Device · Class II · 2014-08-27 · Medtronic Neuromodulation
Reason: Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. - Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784
FDA Device · Class II · 2014-08-20 · Medtronic Neuromodulation
Reason: Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of… - Medtronic Nexdrive Micropositioning Drive
FDA Device · Class II · 2014-08-06 · Medtronic Neuromodulation
Reason: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth. - Medtronic Model 8780 Ascenda Intrathecal Catheter
FDA Device · Class II · 2014-06-11 · Medtronic Neuromodulation
Reason: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. - Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40
FDA Device · Class II · 2014-05-14 · Medtronic Neuromodulation
Reason: This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug with… - Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps
FDA Device · Class II · 2014-05-14 · Medtronic Neuromodulation
Reason: Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intra… - Medtronic, External neurostimulator, ENS (37021) & ENS (37022)
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation
Reason: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of t… - Medtronic neurostimulators
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation
Reason: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of t… - Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neuro…
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation
Reason: Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of t… - Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation
FDA Device · Class II · 2013-11-20 · Medtronic Neuromodulation
Reason: Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. T… - Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603
FDA Device · Class II · 2013-11-20 · Medtronic Neuromodulation
Reason: Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. T… - Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation
FDA Device · Class II · 2013-11-06 · Medtronic Neuromodulation
Reason: Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over… - Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation
FDA Device · Class II · 2013-11-06 · Medtronic Neuromodulation
Reason: Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over… - Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed imp… - Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An e… - Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connecto…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that we… - Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reserv…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed imp… - Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that we… - Medtronic Sutureless Pump Connector Revision Kit, model 8578
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that we… - Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introduce…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that we… - Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reserv…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation
Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An e… - Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic
FDA Device · Class I · 2013-05-08 · Medtronic Neuromodulation
Reason: There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used… - Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339
FDA Device · Class I · 2013-05-08 · Medtronic Neuromodulation
Reason: There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used… - Medtronic Prostiva RF Therapy Generator
FDA Device · Class II · 2013-04-10 · Medtronic Neuromodulation
Reason: Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector por… - Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086
FDA Device · Class II · 2012-12-26 · Medtronic Neuromodulation
Reason: Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked.… - SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump
FDA Device · Class I · 2012-12-19 · Medtronic Neuromodulation
Reason: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of p… - Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
FDA Device · Class I · 2012-12-19 · Medtronic Neuromodulation
Reason: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of p…