Medtronic Neurosurgery
United Statesfrom the FDA registration address FDA establishment FEI 3015531529
- Devices
- 28
- Registrations
- FDA
- FDA recalls
- 6813 ongoing since 2021 (19 open in total)
What Medtronic Neurosurgery makes
The company manufactures cerebrospinal fluid (CSF) management devices, including programmable and non-programmable shunt valves and ventricular/snap shunt catheters designed for hydrocephalus treatment. It also produces dural repair matrices for spinal surgery and external drainage systems for intracranial pressure monitoring. Burr hole locks and lumbar-peritoneal shunt systems are part of its portfolio.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 28 devicesCompany details
- FDA FEI number
- 3015531529
- Address
- 4620 North Beach Street, Fort Worth, TX, 76137
FDA recalls
FDA recall records list 68 recalls initiated by Medtronic Neurosurgery, the earliest on 2003-09-15 and the most recent on 2026-06-17. By recorded status: 19 ongoing and 49 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 1
- 2019 0
- 2020 6
- 2021 3
- 2022 0
- 2023 2
- 2024 7
- 2025 0
- 2026 1
2026
- 17 Jun 2026 Z-2768-2026 Class II Ongoing 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.
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- 17 Jun 2026 Z-2768-2026 Class II Ongoing 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.
2024
- 1 Nov 2024 Z-0661-2025 Class I Ongoing Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
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- 1 Nov 2024 Z-0662-2025 Class I Ongoing Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
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- 22 Jan 2024 Z-1162-2024 Class I Ongoing Potential for catheter disconnection
from the patient line stopcock connectors.
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- 22 Jan 2024 Z-1163-2024 Class I Ongoing Potential for catheter disconnection
from the patient line stopcock connectors.
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- 22 Jan 2024 Z-1164-2024 Class I Ongoing Potential for catheter disconnection
from the patient line stopcock connectors.
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- 22 Jan 2024 Z-1165-2024 Class I Ongoing Potential for catheter disconnection
from the patient line stopcock connectors.
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- 22 Jan 2024 Z-1166-2024 Class I Ongoing Potential for catheter disconnection
from the patient line stopcock connectors.
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- 1 Nov 2024 Z-0661-2025 Class I Ongoing Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
2023
- 28 Jun 2023 Z-2412-2023 Class II Ongoing Product labeling contains incorrect expiration date
- 13 Jun 2023 Z-2207-2023 Class II Ongoing 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.
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Show the 25 most recent of 68 recalls
2021
- 11 Jan 2021 Z-1115-2021 Class II Ongoing Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
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- 11 Jan 2021 Z-1116-2021 Class II Ongoing Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
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- 11 Jan 2021 Z-1117-2021 Class II Ongoing Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
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- 11 Jan 2021 Z-1115-2021 Class II Ongoing Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
2020
- 16 Dec 2020 Z-0871-2021 Class II Open since 2020 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
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- 16 Dec 2020 Z-0872-2021 Class II Open since 2020 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
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- 16 Dec 2020 Z-0873-2021 Class II Open since 2020 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
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- 8 Dec 2020 Z-0738-2021 Class II Open since 2020 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.
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- 8 Dec 2020 Z-0739-2021 Class II Open since 2020 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.
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- 8 Dec 2020 Z-0740-2021 Class II Open since 2020 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.
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- 16 Dec 2020 Z-0871-2021 Class II Open since 2020 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
2018
- 3 May 2018 Z-3212-2018 Class II Terminated 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.
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- 3 May 2018 Z-3212-2018 Class II Terminated 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.
2017
- 20 Dec 2017 Z-0622-2018 Class II Terminated Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
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- 22 Feb 2017 Z-1702-2017 Class I Terminated 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: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.
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- 17 Jan 2017 Z-1121-2017 Class II Terminated 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.
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- 20 Dec 2017 Z-0622-2018 Class II Terminated Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
2014
- 9 Jun 2014 Z-1920-2014 Class I Terminated 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.
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- 9 Jun 2014 Z-1921-2014 Class I Terminated 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.
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- 9 Jun 2014 Z-1920-2014 Class I Terminated 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.
Frequently asked questions
How many devices does Medtronic Neurosurgery have in the registry?
The registry currently lists 28 devices for Medtronic Neurosurgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Neurosurgery's devices?
Among its 28 most recently registered devices, Medtronic Neurosurgery has devices listed in FDA 510(k) (28 devices).
What risk classes do Medtronic Neurosurgery's devices fall under?
Among its 28 most recently registered devices, the classes recorded for Medtronic Neurosurgery's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Neurosurgery?
FDA recall records list 68 recalls initiated by Medtronic Neurosurgery, the most recent initiated on 17 Jun 2026. 19 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medtronic Neurosurgery in the registry?
The most recently registered devices listed for Medtronic Neurosurgery include StrataMR II Valves and Shunts, MEDTRONIC PS MEDICAL STRATA TYPE VALUE, RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 and U-CLIP DEVICE.