Data / Medical devices / United States / Medtronic Neurosurgery
Medtronic Neurosurgery: FDA-registered device maker in Fort Worth, TX, United States, 77 510(k) clearances
Medtronic Neurosurgery is registered with the FDA (registration 3015531529) in Fort Worth, TX, United States. It lists 21 device types. The FDA files 77 510(k) clearances under its listings, the newest dated March 10, 2025. 20 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3015531529
- Address
- 4620 North Beach Street, Fort Worth, TX, United States, 76137
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Specification developer
- First device listed
- November 22, 1992
- Registered through
- 2027
- Brand names listed
- ARES Antibiotic Impregnated Catheters, BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM, BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER, BIPOLAR PENCIL, Becker External Drainage and Monitoring System, CLIP GUN WITH RANEY TYPE SCALP CLIP, CSF CARDIAC PERITONEAL CATHETER, CSF-CARDIAC/PERITONEAL CATHETER 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 |
|---|---|---|---|---|---|---|
| March 10, 2025 | K243676 | Duet External Drainage and Monitoring System (EDMS) | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| October 24, 2024 | K242034 | Duet External Drainage and Monitoring System (EDMS) | PCB | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 16, 2021 | K212641 | StrataMR II Valves and Shunts | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| May 26, 2020 | K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 9, 2020 | K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 26, 2020 | K200456 | Becker External Drainage and Monitoring System | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 1, 2018 | K181622 | StrataMR guider tool | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| April 7, 2016 | K152700 | StrataMR Valves and Shunts | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| August 22, 2014 | DEN120017 | Medtronic DUET External Drainage and Monitoring System | PCB | Unknown | Medtronic Neurosurgery | accessdata.fda.gov |
| February 13, 2013 | K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| November 18, 2011 | K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 2, 2009 | K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| November 20, 2008 | K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| August 27, 2008 | K082127 | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| January 30, 2008 | K073139 | SMALL LUMEN PERITONEAL CATHETER | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| August 16, 2007 | K063836 | RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 15, 2006 | K060681 | MEDTRONIC PS MEDICAL STRATA TYPE VALUE | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 8, 2006 | K062348 | TIMESH SELF DRILLING SCREW | HWC | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| December 16, 2005 | K052386 | MEDTRONIC M2 MAGNET ADJUSTMENT TOOL | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| February 7, 2005 | K050044 | MEDTRONIC CLIP GUN KIT | HBO | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| January 28, 2005 | K041992 | MEDTRONIC STRATAVARIUS | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| November 17, 2004 | K042359 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL | JXG | Substantially Equivalent | Medical Designs, LLC | accessdata.fda.gov |
| October 19, 2004 | K042465 | PS MEDICAL STRATA II VALVE | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| January 13, 2004 | K033850 | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 18, 2001 | K012413 | MACROPORE FX, PS, NS, LP | JEY | Substantially Equivalent | Macropore Biosurgery, Inc. | accessdata.fda.gov |
| July 11, 2001 | K002207 | MACROPOREPX PEDIATRIC SYSTEM | JEY | Substantially Equivalent | Macropore Biosurgery, Inc. | accessdata.fda.gov |
| May 7, 2001 | K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | GXR | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| May 3, 2001 | K010487 | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 | GEI | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| April 20, 2001 | K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | GWG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| February 22, 2001 | K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | GWG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| December 12, 2000 | K002970 | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 | JXG | Substantially Equivalent | Medical Designs, LLC | accessdata.fda.gov |
| November 16, 2000 | K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | GWG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| September 12, 2000 | K991502 | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 | JXG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| April 28, 1999 | K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | GWG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| March 19, 1999 | K983360 | MACROPORE PROTECTIVE SHEET | JEY | Substantially Equivalent | Pacific Materials and Interfaces | accessdata.fda.gov |
| February 4, 1999 | K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| January 26, 1999 | K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | GWM | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| December 16, 1998 | K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | HCA | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| July 30, 1998 | K972913 | MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) | HRS | Substantially Equivalent | Pacific Materials and Interfaces | accessdata.fda.gov |
| June 16, 1998 | K981046 | MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 | JXG | Substantially Equivalent | Medtronic PS Medical | accessdata.fda.gov |
| January 16, 1998 | K974017 | TIMESH SYSTEM | HRS | Substantially Equivalent | Sofamor Danek USA,Inc. | accessdata.fda.gov |
| November 19, 1997 | K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM | JEY | Substantially Equivalent | Sofamor Danek USA,Inc. | accessdata.fda.gov |
| September 19, 1995 | K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | GWG | Substantially Equivalent | Clarus Medical Systems, Inc. | accessdata.fda.gov |
| September 18, 1995 | K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| November 4, 1994 | K942249 | CLARUS NEUROPEN MODEL 2120 | GWG | Substantially Equivalent | Clarus Medical Systems, Inc. | accessdata.fda.gov |
| July 14, 1994 | K934167 | IPI DUAL LUMEN PORT | LJT | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| May 3, 1994 | K940096 | PS MEDICAL CATHETER PLACEMENT KIT | GWG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| April 28, 1994 | K934545 | PS MEDICAL DELTA BURR HOLE VALVE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| September 10, 1993 | K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | GYK | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| April 8, 1993 | K923419 | TISMESH SYSTEM | JEY | Substantially Equivalent | Ti-Mesh, Inc. | accessdata.fda.gov |
| March 30, 1993 | K913412 | PS MEDICAL CSF-ACCESS DEVICE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| January 12, 1993 | K922308 | TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER | FTM | Substantially Equivalent | Ti-Mesh, Inc. | accessdata.fda.gov |
| October 26, 1992 | K923802 | TIMESH TITANIUM MINI-SOFTPLATE/SCREW | JEY | Substantially Equivalent | Ti-Mesh, Inc. | accessdata.fda.gov |
| December 30, 1991 | K915546 | PS MEDICAL VENTRICULOSTOMY KIT | HBG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| September 27, 1991 | K912447 | SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 | FET | Substantially Equivalent | Medical Laser, Inc. | accessdata.fda.gov |
| July 18, 1991 | K911382 | IPI ALGO-LINE CATHETER | MAJ | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| June 28, 1991 | K911410 | PS MEDICAL BUTTON VALVE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| October 3, 1990 | K904283 | PS MEDICAL CRANIAL HAND DRILL | HBG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| August 8, 1990 | K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| March 23, 1990 | K896723 | CLIP GUN WITH RANEY TYPE SCALP CLIPS | HBO | Substantially Equivalent | Omni Medical Designs | accessdata.fda.gov |
| December 21, 1989 | K896167 | PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| February 11, 1988 | K874498 | CSF-VENTRICULOSTOMY RESERVOIR | LKG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| February 11, 1988 | K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | LKG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| September 18, 1987 | K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| May 22, 1987 | K871752 | CSF-CARDIAC/PERITONEAL CATHETER | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| December 3, 1986 | K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| August 12, 1986 | K862303 | BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| May 25, 1984 | K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | LKG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| April 19, 1984 | K841442 | P-S MEDICAL CSF-FLOW CONTROL VALVE- | JXG | Substantially Equivalent | P-S Medical | accessdata.fda.gov |
| August 12, 1983 | K831396 | P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| June 24, 1983 | K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| March 9, 1983 | K823503 | P-S CSF-VENTRICULAR CATHETER, FLANGED | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| December 16, 1982 | K823509 | P-S MED. LUMBO PERITONEAL & VENTRICULO- | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| January 22, 1981 | K803257 | CSG-FLOW CONTROL VALVE | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| September 16, 1980 | K802100 | INTRACRANIAL PRESSURING MONITORING SYST. | GWM | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| January 16, 1980 | K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
| January 16, 1980 | K792005 | CSF-CARDIAC/PERITONEAL CATHETER | JXG | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2026 | 99342 | Class II | Ongoing | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process. | accessdata.fda.gov |
| November 1, 2024 | 95725 | Class I | Ongoing | Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). | accessdata.fda.gov |
| January 22, 2024 | 93919 | Class I | Ongoing | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. | Potential for catheter disconnection from the patient line stopcock connectors. | accessdata.fda.gov |
| June 28, 2023 | 92702 | Class II | Ongoing | Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only | Product labeling contains incorrect expiration date | accessdata.fda.gov |
| June 13, 2023 | 92514 | Class II | Ongoing | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection. | accessdata.fda.gov |
| January 11, 2021 | 87157 | Class II | Ongoing | Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 2 | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus | accessdata.fda.gov |
| December 16, 2020 | 87069 | Class II | Ongoing | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide cont | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction | accessdata.fda.gov |
| December 8, 2020 | 86988 | Class II | Ongoing | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. | There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention. | accessdata.fda.gov |
| May 3, 2018 | 80657 | Class II | Terminated | Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO | The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged, it is possible that the seal breach may go undetected by the user's naked eye. | accessdata.fda.gov |
| December 20, 2017 | 78997 | Class II | Terminated | Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10) | Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. | accessdata.fda.gov |
| February 22, 2017 | 76595 | Class I | Terminated | The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The desi | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventricu | accessdata.fda.gov |
| January 17, 2017 | 76249 | Class II | Terminated | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image. | accessdata.fda.gov |
| June 9, 2014 | 68503 | Class I | Terminated | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. | accessdata.fda.gov |
| November 18, 2013 | 66882 | Class II | Terminated | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. | accessdata.fda.gov |
| June 28, 2013 | 65600 | Class II | Terminated | Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms | Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit. | accessdata.fda.gov |
| February 12, 2009 | 51287 | Not yet classified | Terminated | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. | accessdata.fda.gov |
| March 8, 2006 | 35046 | Not yet classified | Terminated | Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The | Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws. | accessdata.fda.gov |
| July 5, 2005 | 32595 | Not yet classified | Terminated | Medtronic Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F | Cracked hubs/handles and/or improper peeling of the sheath during use. | accessdata.fda.gov |
| February 28, 2005 | 31283 | Not yet classified | Terminated | MurphyScope, Bayonet, Malleable, Catalog # 2121-157 | Products are mislabeled. | accessdata.fda.gov |
| September 15, 2003 | 27299 | Not yet classified | Terminated | Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001 | Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Central Nervous System And Components
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Port & Catheter, Implanted, Subcutaneous, Intraventricular
- All makers of Plate, Bone
- All makers of Instrument, Shunt System Implantation
Updated July 21, 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.