The Recall Desk

Manufacturer

Medtronic Neurosurgery

32 recalls in our database name Medtronic Neurosurgery as the manufacturing or recalling firm.

What the numbers show

Total
32
Critical
0
Severe
11
Most recent
2026-07-29

Of the 32 recalls from Medtronic Neurosurgery we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (34%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 32

  • SevereFDA (Devices)·Z-0662-2025·2024-12-25

    Exacta External Drainage System Stopcocks May Leak or Crack

    Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.

    Product
    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0661-2025·2024-12-25

    Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks

    Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.

    Product
    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 BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1162-2024·2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1165-2024·2024-03-06

    Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk

    Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1163-2024·2024-03-06

    Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk

    Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2024·2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1164-2024·2024-03-06

    Medtronic Duet External Drainage System catheter disconnection risk recalled

    Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2412-2023·2023-08-23

    Medtronic ventricular catheter system recalled due to incorrect labeling expiration date

    Medtronic is recalling 44 units of the Duet External Drainage and Monitoring system because the product labels contain an incorrect expiration date. The affected lot (226632942) was distributed nationwide.

    Product
    Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2023·2023-07-26

    Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination

    Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.

    Product
    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 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2021·2021-02-24

    Medtronic Recalls Cerebrospinal Fluid Valves Due to Radiopaque Marking Issues

    Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid valves and shunts worldwide because radiopaque markings may vary in visibility under imaging.

    Product
    Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 2781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2021·2021-02-24

    Medtronic CSF-Flow Control Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic Neurosurgery is recalling 20,817 CSF-Flow Control Valves worldwide due to potential variation in radiopaque marking visibility under radiographic imaging.

    Product
    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2021·2021-02-24

    Medtronic Delta CSF Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic is recalling Delta CSF flow control valves because radiopaque markings may not be clearly visible under X-ray imaging.

    Product
    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 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 2512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0871-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    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 controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0873-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.

    Product
    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0872-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recall for Seal Defect

    Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

    Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

    Product
    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2021·2021-01-06

    Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect

    Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.

    Product
    Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2018·2018-10-03

    Medtronic Clip Gun Magazines Recalled for Packaging Sterility Defect

    Medtronic Neurosurgery is recalling Clip Gun Magazines because the packaging sterile barrier may be compromised without visible signs.

    Product
    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, Rx only, Single Use
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0622-2018·2018-02-21

    Medtronic Recalls Clip Gun Scalp Clip Kits Due to Packaging Defects

    Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.

    Product
    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)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1702-2017·2017-04-19

    Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

    Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.

    Product
    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 design enables the physician to non-invasive adjust valve pressu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1121-2017·2017-02-08

    Medtronic Strata II Valves Recalled for Pressure Discrepancies

    Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.

    Product
    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 designed to allow for continuous flow of cerebrospinal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1923-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar
    Category
    Medical Device
    Distribution
    1 state