Every recall we track for Medtronic Neuromodulation — 59 in all — plus the complaints and injury reports the public filed about them.
Medtronic recalls certain Pocket Adaptor Kits for Deep Brain Stimulation due to incorrect Use-By-Dates on labels. Affected kits include specific model numbers and lot numbers.
Medtronic recalls 1x4 Pocket Adaptor Kits for Deep Brain Stimulation with incorrect Use-By-Dates. Model 64001 and 64002 kits have specific lot numbers and GTINs listed in the recall.
Medtronic recalls certain SynchroMed Flex Infusion Programmer software versions that may display infusion steps out of order, causing missed medication schedules. Affected devices include specific clinician tablets with model numbers CT900A through CT900F and software versions 1.x and 2.x.
Medtronic recalls specific versions of their Vanta Clinician Programmer software for Samsung tablets due to potential delays in surgical procedures. Affected users should contact Medtronic for details.
Medtronic recalls Restore Clinician Programmer App Model A71100 software versions before v.1.0.4489. Rare device reset issues may cause pain recurrence. Affected users should contact Medtronic for repair or replacement.
Medtronic recalls Enhanced Verify Evaluation Handsets (CFN HH90130FA) due to potential communication failure with neurostimulators, which may cause therapy interruption and return of symptoms like urinary retention or incontinence.
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application Model A71400 when used with specific neurostimulators due to a software issue that can permanently disable communication with implantable neurostimulators during certain programming sequences.
Medtronic recalls A820 myPTM software for SynchroMed pumps due to delayed patient interactions with implantable pumps. Affected units have specific version and UDI/DI numbers.
Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E clinician tablets that have software version 2.x. This recall addresses potential software issues that could affect device function.
Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps with software version 2.x that may have software issues.
Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 pumps used with PROG CT900C Clinician Tablet UK due to software issues in version 2.x. Affected units require software update to prevent potential malfunctions.
Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps with specific software versions due to potential software issues. Affected units include certain serial numbers and GTINs.
Medtronic recalls 12 specific model B35300 implantable neurostimulators that fail to communicate with the A610 Clinician Programmer, showing an 'Invalid Device' message. Affected units have unique serial numbers and GTINs listed in the recall.
Medtronic recalls Recharger Kits RS6230, RS7230, and RS5220A that may fail to enter recharging session upon first use. Affected units include specific serial numbers and models for deep brain stimulation and pelvic health systems.
Medtronic recalls SynchroMed II Infusion Pumps (Product 8637-20) due to potential data corruption causing pump errors and inability to check settings. Affected units have specific serial numbers.
Medtronic recalls specific Handset with Communicator models TH90Q01 that may fail to pair with communicator during initial setup. Affected units have serial numbers listed in the recall notice.
Medtronic Neuromodulation
Medtronic recalls specific models of Ascenda Intrathecal Catheters (8780, 8781, 8784) due to a design update that may lead to tissue growth in the catheter connector, potentially causing occlusion. Affected units have unique serial numbers listed in the recall.
Medtronic recalls Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 due to inability to reprogram one device. Affected units have UDI/DI 00643169781719.
Medtronic recalls its A710 Clinician Programmer Application version 2.0.97 due to potential inability to adjust pain therapy settings, risking inadequate or excessive treatment for patients.
Medtronic recalls SynchroMed II programmable pumps (model 8637-40) that may stop drug delivery after MRI scans due to electromagnetic interference. Affected units have specific serial numbers and GTINs.
Medtronic recalls SynchroMed II programmable pumps (model 8637-20) due to potential failure to resume drug delivery after MRI scans when electromagnetic interference occurs. Affected units have specific serial numbers listed in the recall.
Medtronic Neuromodulation recalls Model 97745 controllers used with specific neurostimulators in Korea and Turkey due to incorrect firmware installation for local language interfaces. Affected units have unique serial numbers and UDI/DI codes.
Medtronic recalls InterStim Ground Pad REF 041826 due to incorrect expiration date labeling. Affected units may have safety risks if used beyond the correct date.
Medtronic recalls A901 Communication Manager software for Intellis Neurostimulation System. Missing update for A710 Clinician Programmer causes compatibility issues. Affected units have specific serial numbers.
Medtronic recalls Vanta with AdaptiveStim Implantable Neurostimulator Model 977006 due to potential spinal chord stimulation causing device failure. Two patients reported explant procedures after the issue occurred.
Medtronic recalls SenSight Extension Tunneler Kit REF B31030 with dual carriers machined on one side, preventing simultaneous extension passage. Affected units have specific serial numbers and UDI/DI codes.
Medtronic is recalling a small number of SenSight Connector Plug Model B31061 units due to a discrepancy in the Use By Date label. Affected units have a specific lot number and GTIN.
Medtronic recalls Vanta/Seqenita LT Clinician Programmer (Model CT900D) due to software anomalies causing messages like 'Too Many Device Found' and 'Unexpected Device Error Code 1502'.
Medtronic recalls Vanta/Seqenita LT Clinician Programmer Application (Model CT900B) due to software anomalies causing error messages like 'Too Many Device Found' and 'Unexpected Device Error Code 1502'.
Medtronic recalls Vanta/Seqenita LT Clinician Programmer (Model CT900E) due to software errors causing device message alerts. Affected units have specific serial numbers listed in the recall.
Medtronic recalls Vanta/Seqenita LT Clinician Programmer software with error messages like 'Too Many Device Found' and 'Unexpected Device Error Code 1502' for pain therapy systems. Affected units may experience software issues.
Medtronic recalls Vanta Clinician Programmer App version 2.0.2455 for pain therapy devices that may show error 1502, preventing programming of implantable neurostimulators.
Medtronic recalls Vanta Clinician Programmer App version 2.0.2455 for potential connection issues with patients using multiple neurostimulators. This software update may prevent proper communication with implantable devices.
Medtronic recalls LEAD 3387S-40 STIMLOC DBS devices due to a discrepancy between Use By Dates on the product and kit labels. Affected units may have expired components.
Medtronic recalls Percept BrainSense Implantable Neurostimulator (INS) Model B35200 due to inability to communicate with clinical and patient programmers. Affected units have specific serial numbers and expiration dates. No remedy is listed in the recall notice.
Medtronic recalls Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication issues with clinical programmer systems. Affected devices may not function properly.
Medtronic recalls Vanta INS Implantable Neurostimulators with AdaptiveStim Technology that may not communicate properly with clinical or patient programming systems. Affected models include specific serial numbers and expiration dates listed in the recall notice.
Medtronic recalls InterStim therapy systems for urinary control with software that loses patient data. Affected models include TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01, A51300, and A52300. Data entered in patient fields may not be retained, showing a 'Data Lost' notification.
Medtronic recalls WR9220 wireless rechargers in RS5200 kits for InterStim implants. These devices become unresponsive if charging steps in the patient guide aren't followed.
Medtronic recalls wireless recharger model WR9200 (included in RS6200 Recharger Kit for Activa RC 37612) that becomes unresponsive if charging steps aren't followed. No immediate safety risk but requires attention to prevent device malfunction.
Medtronic recalls wireless rechargers (WR9200) for RestoreUltra and RestoreSensor devices that become unresponsive if charging steps aren't followed. Affected units include specific implantable neurostimulators.
Medtronic recalls Model B35200 Percept PC BrainSense Implantable Neurostimulators that may become unresponsive during cardioversion procedures, potentially causing circuit damage. Affected units have specific serial numbers listed in the recall.
Medtronic recalls Clinician Programmer Application software versions 3.0.1048-1081 for potential software anomalies. Affected users should check their software version and contact Medtronic for updates.
Medtronic recalls Vectris SureScan MRI devices with specific catalog numbers due to incorrect lead electrode spacing information on packaging. This could lead to improper use during MRI procedures.
Recall of Medtronic StimLoc Burr Hole Covers with specific part numbers and lots due to excess nylon flash. Consumers should check their product details to determine if affected.
Medtronic recalls Intellis Model 97755 rechargeers due to potential unintended heating. Affected units charge Medtronic neurostimulators with specific serial numbers. Stop using immediately to prevent injury.
Medtronic recalls specific versions of its Percept PC clinician programmer software due to cycling and log fill problems that could cause crashes when copying settings or reading logs.
Medtronic recalls Percept PC implantable neurostimulators due to software failure preventing device connection. Affected units have specific model and serial numbers.
Medtronic recalls Intellis Spinal Cord Stimulator model A710 software version 1.3.80 due to inability to program the implantable neurostimulation device. Affected users should contact Medtronic for assistance.
Medtronic recalls version 1.0.4232 of the Restore Clinician Programmer Application Software (model A71100) due to compatibility issues with some legacy software, preventing communication with implanted neurostimulators.
Medtronic recalls InterStim systems with model numbers TH90G01, TH90GFA, TH90G02, TH90G03 due to potential unexpected stimulation during programming. Affected users should contact Medtronic for details.
Recall of Medtronic Vectris Sure Scan MRI Lead Kits (models 977A160, 977A175, 977A190, 977A260, 977A275, 977A290) due to potential manufacturing defect in curved tip introducer needle causing difficulty advancing or withdrawing the lead.
Medtronic recalls Vectris Trial Screening Lead Kits (models 977D160 and 977D260) due to a potential manufacturing defect in the curved tip introducer needle that may cause difficulty advancing or withdrawing the lead during spinal cord stimulation implantation.
