Medtronic Neurosurgery

FDA Regulatory Profile

Summary

Total Recalls
31 (13 Class I)
510(k) Clearances
28
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0662-2025Class IExacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM November 1, 2024
Z-0661-2025Class IBecker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25November 1, 2024
Z-1162-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, SterilJanuary 22, 2024
Z-1166-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, January 22, 2024
Z-1163-2024Class IMedtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, SteriJanuary 22, 2024
Z-1164-2024Class IMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular CatheJanuary 22, 2024
Z-1165-2024Class IMedtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular CatheJanuary 22, 2024
Z-2412-2023Class IIMedtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, VentricJune 28, 2023
Z-2207-2023Class IIDurepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTJune 13, 2023
Z-1115-2021Class IIMedtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:January 11, 2021
Z-1117-2021Class IIMedtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 220January 11, 2021
Z-1116-2021Class IIMedtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for thJanuary 11, 2021
Z-0872-2021Class IIREF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - ProdDecember 16, 2020
Z-0873-2021Class IIREF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - ProdDecember 16, 2020
Z-0871-2021Class IIREF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - ProdDecember 16, 2020
Z-0738-2021Class IIMedtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatmDecember 8, 2020
Z-0740-2021Class IIMedtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatmentDecember 8, 2020
Z-0739-2021Class IIMedtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatmeDecember 8, 2020
Z-3212-2018Class IIMedtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes coMay 3, 2018
Z-0622-2018Class IIModel #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun ScalDecember 20, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K243676Duet External Drainage and Monitoring System (EDMS)March 10, 2025
K242034Duet External Drainage and Monitoring System (EDMS)October 24, 2024
K212641StrataMR II Valves and ShuntsSeptember 16, 2021
K181622StrataMR guider toolOctober 1, 2018
K161370Durepair Dura Regeneration MatrixNovember 2, 2016
K152700StrataMR Valves and ShuntsApril 7, 2016
DEN120017Medtronic DUET External Drainage and Monitoring SystemAugust 22, 2014
K123524MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMFebruary 13, 2013
K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERNovember 18, 2011
K091312PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMSeptember 2, 2009
K083076STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836November 20, 2008
K082127STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635August 27, 2008
K073139SMALL LUMEN PERITONEAL CATHETERJanuary 30, 2008
K063836RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-417August 16, 2007
K062821U-CLIP DEVICEDecember 19, 2006
K063117MODIFICATION TO DUREPAIR DURA REGENERATION MATRIXNovember 3, 2006
K060681MEDTRONIC PS MEDICAL STRATA TYPE VALUESeptember 15, 2006
K062348TIMESH SELF DRILLING SCREWSeptember 8, 2006
K052386MEDTRONIC M2 MAGNET ADJUSTMENT TOOLDecember 16, 2005
K052211DUREPAIR DURA REGENERATION MATRIXSeptember 14, 2005