Data / Medical devices / United States / Medtronic Neuromodulation
Medtronic Neuromodulation: FDA-registered device maker in Minneapolis, MN, United States, 13 510(k) clearances and 7 PMA approvals
Medtronic Neuromodulation is registered with the FDA (registration 2182207) in Minneapolis, MN, United States. It lists 26 device types. The FDA files 13 510(k) clearances and 7 PMA approvals under its listings, the newest dated September 18, 2025. 116 recall events name it as the recalling firm (7 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2182207
- Address
- 7000 Central Ave., N.E., Minneapolis, MN, United States, 55432
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 2, 1992
- Registered through
- 2026
- Brand names listed
- 1 X 8 Test Stimulation Lead, 3875 1 X 8 Subcompact Lead, Access Review Therapy Controller, Access Therapy Controller, Activa Dystonia Therapy, Activa PC Neurostimulator, Activa Parkinsons Control Therapy, Activa RC Neurostimulator and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2021 | DEN210003 | SureTune4 Software | QQC | Unknown | Medtronic Neuromodulation | accessdata.fda.gov |
| November 5, 2013 | K132561 | NURO NEUROMODULATION SYSTEM | NAM | Substantially Equivalent | Advanced Uro-Solutions, Inc. | accessdata.fda.gov |
| October 26, 2010 | K102523 | MULTI-LEAD TRIALING CABLE MODEL 355531 | GZB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 16, 2006 | K062041 | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | GZB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 28, 2005 | K051773 | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS | GZB | Substantially Equivalent | Medtronic Inc.,Neurological Division. | accessdata.fda.gov |
| March 25, 2004 | K040568 | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | GZB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| August 21, 2003 | K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | HBL | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| January 24, 2002 | K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | GZB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| October 25, 2000 | K001096 | BURR HOLE COVER, MODEL XX | GXR | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| April 12, 2000 | K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | GZF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 1, 2000 | K994097 | MEDAMICUS EPIDURAL INTRODUCER | GZB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| May 21, 1996 | K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | GZF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| November 5, 1992 | K923567 | MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD | GZB | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 18, 2025 | P240011 | Medtronic Altaviva System | QPT | 15 | September 14, 2026 | accessdata.fda.gov |
| March 14, 2011 | P080025 | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | QON | 349 | October 9, 2026 | accessdata.fda.gov |
| July 21, 2000 | P990034 | MEDTRONIC ISOMED INFUSION SYSTEM | LKK | 36 | November 22, 2024 | accessdata.fda.gov |
| September 29, 1997 | P970004 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | EZW | 448 | October 9, 2026 | accessdata.fda.gov |
| July 31, 1997 | P960009 | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM | MHY | 528 | October 6, 2026 | accessdata.fda.gov |
| March 14, 1988 | P860004 | MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM | LKK | 442 | October 16, 2026 | accessdata.fda.gov |
| November 30, 1984 | P840001 | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | LGW | 612 | October 6, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 116.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | 99949 | Class II | Ongoing | InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSM | Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product. | accessdata.fda.gov |
| May 13, 2026 | 98913 | Class II | Ongoing | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | accessdata.fda.gov |
| April 8, 2026 | 98750 | Class II | Ongoing | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, i | accessdata.fda.gov |
| December 3, 2025 | 98097 | Class II | Ongoing | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900). | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. | accessdata.fda.gov |
| November 20, 2025 | 98028 | Class II | Ongoing | Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET U | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS. | accessdata.fda.gov |
| April 3, 2025 | 96688 | Class II | Ongoing | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, | accessdata.fda.gov |
| March 4, 2025 | 96445 | Class II | Ongoing | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. | accessdata.fda.gov |
| January 9, 2025 | 96237 | Class II | Ongoing | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. | accessdata.fda.gov |
| November 21, 2024 | 95845 | Class II | Ongoing | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B | Software issues were identified in application version 2.x. | accessdata.fda.gov |
| September 24, 2024 | 95489 | Class II | Ongoing | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. | accessdata.fda.gov |
| September 18, 2024 | 95465 | Class II | Ongoing | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977 | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | accessdata.fda.gov |
| September 11, 2024 | 95419 | Class II | Ongoing | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | accessdata.fda.gov |
| August 21, 2024 | 95281 | Class II | Ongoing | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. | accessdata.fda.gov |
| June 17, 2024 | 95131 | Class II | Ongoing | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator. | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. | accessdata.fda.gov |
| May 15, 2024 | 94845 | Class II | Ongoing | A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Ver | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. | accessdata.fda.gov |
| May 10, 2024 | 94779 | Class II | Ongoing | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion. | accessdata.fda.gov |
| March 28, 2024 | 94338 | Class II | Ongoing | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | accessdata.fda.gov |
| December 19, 2023 | 93714 | Class II | Ongoing | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and exp | accessdata.fda.gov |
| November 13, 2023 | 93481 | Class II | Ongoing | Medtronic SynchroMed II, Model 8637-20, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling. | accessdata.fda.gov |
| October 19, 2023 | 93303 | Class II | Ongoing | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators | Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. | accessdata.fda.gov |
| July 6, 2023 | 92701 | Class II | Ongoing | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. | accessdata.fda.gov |
| June 21, 2023 | 92530 | Class II | Ongoing | A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. | When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download. | accessdata.fda.gov |
| June 6, 2023 | 92413 | Class II | Ongoing | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation | A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures. | accessdata.fda.gov |
| March 17, 2023 | 91957 | Class II | Ongoing | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation | Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously. | accessdata.fda.gov |
| January 20, 2023 | 93083 | Class II | Ongoing | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label. | accessdata.fda.gov |
| December 3, 2022 | 91296 | Class II | Ongoing | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" | accessdata.fda.gov |
| July 26, 2022 | 90686 | Class II | Ongoing | Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy. | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006. | accessdata.fda.gov |
| July 26, 2022 | 90685 | Class II | Ongoing | Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy. | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator. | accessdata.fda.gov |
| May 27, 2022 | 93170 | Class II | Completed | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label. | accessdata.fda.gov |
| March 30, 2022 | 89994 | Class II | Ongoing | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. | accessdata.fda.gov |
| March 30, 2022 | 89971 | Class II | Ongoing | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy. | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. | accessdata.fda.gov |
| February 28, 2022 | 89799 | Class II | Terminated | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Ther | There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed. | accessdata.fda.gov |
| November 4, 2021 | 88953 | Class II | Ongoing | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator. | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed. | accessdata.fda.gov |
| October 19, 2021 | 88889 | Class II | Ongoing | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Perc | accessdata.fda.gov |
| September 23, 2021 | 88761 | Class II | Ongoing | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | accessdata.fda.gov |
| July 9, 2021 | 88272 | Class II | Ongoing | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 | Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling. | accessdata.fda.gov |
| June 2, 2021 | 88160 | Class II | Ongoing | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000 | Excess nylon flash on the clip. | accessdata.fda.gov |
| March 25, 2021 | 87674 | Class II | Ongoing | Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 I | There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. | accessdata.fda.gov |
| March 9, 2021 | 87569 | Class II | Ongoing | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is | 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 the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Even | accessdata.fda.gov |
| November 19, 2020 | 86907 | Class II | Terminated | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, d | A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. | accessdata.fda.gov |
| November 12, 2020 | 86872 | Class II | Ongoing | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators | A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. | accessdata.fda.gov |
| July 17, 2020 | 92798 | Class II | Terminated | Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators. | The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators. | accessdata.fda.gov |
| October 11, 2019 | 84037 | Class I | Terminated | Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 | 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. | accessdata.fda.gov |
| May 15, 2019 | 82626 | Class II | Ongoing | InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to prog | There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer). | accessdata.fda.gov |
| May 25, 2018 | 80256 | Class II | Terminated | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional | 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 Vectris lead through the curved tip introducer needle. | accessdata.fda.gov |
| September 21, 2017 | 78406 | Class III | Terminated | Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 87 | 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. | accessdata.fda.gov |
| August 9, 2017 | 78609 | Class II | Ongoing | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and deliver | 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. | accessdata.fda.gov |
| March 17, 2017 | 77839 | Class II | Terminated | DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead im | 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. | accessdata.fda.gov |
| February 9, 2017 | 76591 | Class II | Terminated | SynchroMed II implantable drug infusion pump, Model 8637-40 | 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 the pump; however the pump was providing therapy. | accessdata.fda.gov |
| October 3, 2016 | 75486 | Class I | Terminated | Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump | 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 SynchroMed pump labeling to address the priming bolus issue. | accessdata.fda.gov |
| October 3, 2016 | 75458 | Class II | Terminated | Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The | 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 Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 secon | accessdata.fda.gov |
| June 23, 2016 | 74552 | Class II | Terminated | 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 neurostimulation system for deep brain stimulation. The pocket adaptor is inten | 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 for the handling of pocket adaptors and system integrity checking during implant procedures. | accessdata.fda.gov |
| June 10, 2016 | 74545 | Class II | Terminated | Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V). | 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 potential for lead insulation damage. | accessdata.fda.gov |
| May 3, 2016 | 74059 | Class II | Terminated | Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pai | 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 depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge | accessdata.fda.gov |
| February 9, 2016 | 73426 | Class II | Terminated | Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide. | 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 result, it may not contain all components necessary to complete the implant procedure. | accessdata.fda.gov |
| January 11, 2016 | 73139 | Class II | Terminated | Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or | Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use. | accessdata.fda.gov |
| April 16, 2015 | 71016 | Class II | Terminated | Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile | 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 following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603). | accessdata.fda.gov |
| April 10, 2015 | 71047 | Class II | Terminated | Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a | 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. | accessdata.fda.gov |
| January 9, 2015 | 70271 | Class II | Terminated | The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension an | 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, longevity estimate displayed on the Model 8840Programmer may be inaccurate. | accessdata.fda.gov |
| July 14, 2014 | 68935 | Class II | Terminated | Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains | Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. | accessdata.fda.gov |
| July 11, 2014 | 68838 | Class II | Terminated | Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers | 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 the catheter, the retainer ring, not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter fr | accessdata.fda.gov |
| June 11, 2014 | 68615 | Class II | Terminated | Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereo | 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. | accessdata.fda.gov |
| May 2, 2014 | 68295 | Class II | Terminated | Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The i | Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits. | accessdata.fda.gov |
| April 4, 2014 | 68031 | Class II | Terminated | Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implanta | 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 Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks a | accessdata.fda.gov |
| February 27, 2014 | 66841 | Class II | Terminated | Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37 | 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 this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves dev | accessdata.fda.gov |
| February 26, 2014 | 67720 | Class II | Terminated | Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a sp | 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 withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pum | accessdata.fda.gov |
| September 30, 2013 | 66506 | Class II | Terminated | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. | 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. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR). | accessdata.fda.gov |
| September 30, 2013 | 66473 | Class II | Terminated | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stim | 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 discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. | accessdata.fda.gov |
| June 3, 2013 | 65443 | Class I | Terminated | 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 is part of an infusion system that stores and delivers a prescribed dr | 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 electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therap | accessdata.fda.gov |
| June 3, 2013 | 65342 | Class I | Terminated | Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed i | 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 were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and s | accessdata.fda.gov |
| June 3, 2013 | 65135 | Class I | Terminated | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers | 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 implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically rele | accessdata.fda.gov |
| February 27, 2013 | 64497 | Class II | Terminated | Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with | 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 port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depe | accessdata.fda.gov |
| February 8, 2013 | 64439 | Class I | Terminated | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected tar | 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. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the | accessdata.fda.gov |
| December 3, 2012 | 63777 | Class II | Terminated | Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulat | 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. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot. | accessdata.fda.gov |
| November 9, 2012 | 63712 | Class I | Terminated | 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 implanted infusion system that consists of a SynchroMed EL pump and a ca | 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 permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroM | accessdata.fda.gov |
| March 12, 2012 | 61391 | Not yet classified | Terminated | Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 | Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the ret | accessdata.fda.gov |
| July 5, 2011 | 59317 | Not yet classified | Terminated | 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 is part of an infusion system that stores and delivers a prescribed dr | Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occ | accessdata.fda.gov |
| January 14, 2011 | 57651 | Not yet classified | Terminated | Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal ( | This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. A pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subc | accessdata.fda.gov |
| September 29, 2010 | 57024 | Not yet classified | Terminated | Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 The implantable Medtronic Model 8 | Medtronic is recalling specific lots of Model 8731SC intrathecal catheter kits and Model 8598A intrathecal catheter spinal revision kits because there is the potential that the 11.4 cm introducer needles within these kits may exceed USP requirements for bacterial endotoxin. | accessdata.fda.gov |
| October 27, 2009 | 53689 | Not yet classified | Terminated | Medtronic Accessory Kit, Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604 | Medtronic is issuing a medical device correction for the Model 3550-39 Titan anchor due to the potential for lead migration as a result of insert separation within the anchor. The Medtronic Model 3550-39 Titan anchor accessory kit is designed for use with Medtronic percutaneous in-line connector spinal cord stimulation leads. Medtronic has received reports o | accessdata.fda.gov |
| August 27, 2009 | 53129 | Not yet classified | Terminated | Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The implanted infusion system components consist of a Medtronic pump and a | Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. Medtronic has determined that SC catheters are no | accessdata.fda.gov |
| August 25, 2009 | 53086 | Not yet classified | Terminated | Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, | Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical interv | accessdata.fda.gov |
| July 1, 2009 | 52730 | Not yet classified | Terminated | Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected prod | This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performa | accessdata.fda.gov |
| March 23, 2009 | 54477 | Not yet classified | Terminated | Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. | Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump progr | accessdata.fda.gov |
| August 25, 2008 | 49603 | Not yet classified | Terminated | Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump | Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration | accessdata.fda.gov |
| June 26, 2008 | 48761 | Not yet classified | Terminated | Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6 cm catheter and connector pin, Transp | Disconnection of the Medtronic sutureless connector (SC) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump. | accessdata.fda.gov |
| June 14, 2008 | 49446 | Not yet classified | Terminated | Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation, length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead | Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may t | accessdata.fda.gov |
| June 5, 2008 | 50856 | Not yet classified | Terminated | PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, | Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. | accessdata.fda.gov |
| May 21, 2008 | 48705 | Not yet classified | Terminated | Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model | Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit. | accessdata.fda.gov |
| May 12, 2008 | 48752 | Not yet classified | Terminated | Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimu | Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device. | accessdata.fda.gov |
| May 1, 2008 | 48635 | Not yet classified | Terminated | Medtronic Synchromed II Programmable Pump, Medtronic Inc., Minneapolis, MN 55432-5604 20 ml Pumps Model 8637-20 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System desig | SynchroMed II pumps (non-implanted) may have been manufactured without propellant. | accessdata.fda.gov |
| April 25, 2008 | 48612 | Not yet classified | Terminated | Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Caps | The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube. | accessdata.fda.gov |
| April 14, 2008 | 48616 | Not yet classified | Terminated | Medtronic 8578 Sutureless Pump Connector Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy | The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period. | accessdata.fda.gov |
| March 1, 2008 | 48070 | Not yet classified | Terminated | Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only | Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length. | accessdata.fda.gov |
| February 4, 2008 | 47755 | Not yet classified | Terminated | IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml l | Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death. | accessdata.fda.gov |
| January 16, 2008 | 46685 | Not yet classified | Terminated | Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Inc., 710 Medtronic Pa | Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent | accessdata.fda.gov |
| January 9, 2008 | 46814 | Not yet classified | Terminated | Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC. | Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin. | accessdata.fda.gov |
| December 3, 2007 | 46044 | Not yet classified | Terminated | Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001. Medtronic, Inc., Minneapolis, MN 55432 | Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall. | accessdata.fda.gov |
| October 1, 2007 | 45847 | Not yet classified | Terminated | Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device a | Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy. | accessdata.fda.gov |
| August 3, 2007 | 45595 | Not yet classified | Terminated | Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL | Pump Motor Stall; pumps can stall due to gear shaft wear. | accessdata.fda.gov |
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Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.