Medtronic Neurosurgery recalls
Medtronic Neurosurgery appears in 32 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 32 |
|---|---|
| Published | 2013-07-31 to 2026-07-29 |
| By agency | FDA Device (32) |
| By classification | Class II (19), Class I (13) |
| By status | ongoing (19), terminated (13) |
| Distribution named in notices | AL, AR, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- Ventriculostomy Kit, REF: 46154
FDA Device · Class II · 2026-07-29 · Medtronic Neurosurgery
Reason: 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 cerebrospin… - Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery
Reason: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). - 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…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery
Reason: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
Reason: Potential for catheter disconnection from the patient line stopcock connectors. - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
Reason: Potential for catheter disconnection from the patient line stopcock connectors. - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
Reason: Potential for catheter disconnection from the patient line stopcock connectors. - Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
Reason: Potential for catheter disconnection from the patient line stopcock connectors. - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
Reason: Potential for catheter disconnection from the patient line stopcock connectors. - Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
FDA Device · Class II · 2023-08-23 · Medtronic Neurosurgery
Reason: Product labeling contains incorrect expiration date - Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100
FDA Device · Class II · 2023-07-26 · Medtronic Neurosurgery
Reason: 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 p… - Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 2…
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery
Reason: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus - Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 2…
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery
Reason: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus - Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery
Reason: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus - REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery
Reason: 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… - REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery
Reason: 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… - REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
FDA Device · Class II · 2021-01-27 · Medtronic Neurosurgery
Reason: 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… - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery
Reason: 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 me… - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery
Reason: 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 me… - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery
Reason: 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 me… - Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gu…
FDA Device · Class II · 2018-10-03 · Medtronic Neurosurgery
Reason: 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… - Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1)
FDA Device · Class II · 2018-02-21 · Medtronic Neurosurgery
Reason: Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. - The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles o…
FDA Device · Class I · 2017-04-19 · Medtronic Neurosurgery
Reason: 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 leadin… - Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal
FDA Device · Class II · 2017-02-08 · Medtronic Neurosurgery
Reason: 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 va… - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery
Reason: 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 patie… - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery
Reason: 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 patie… - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery
Reason: 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 patie… - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery
Reason: 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 patie… - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915
FDA Device · Class I · 2014-07-09 · Medtronic Neurosurgery
Reason: 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 patie… - CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery
Reason: 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. - Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery
Reason: 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. - Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery
Reason: 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. - Medtronic Preimplantation Test Kit, Catalog No. 21047
FDA Device · Class II · 2013-07-31 · Medtronic Neurosurgery
Reason: 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 mor…