The Recall Desk

Manufacturer

Stryker Neurovascular

109 recalls in our database name Stryker Neurovascular as the manufacturing or recalling firm.

What the numbers show

Total
109
Critical
0
Severe
3
Most recent
2026-07-01

Of the 109 recalls from Stryker Neurovascular we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) 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 109

  • HighFDA (Devices)·Z-2552-2026·2026-07-01

    Stryker Neurovascular INZONE Detachment System battery drain

    Stryker Neurovascular is recalling the INZONE Detachment System (REF: M00345100950) due to premature battery drain that may prevent the device from powering on or detaching coils as intended.

    Product
    INZONE DETACHMENT SYSTEM, REF: M00345100950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2025·2024-10-16

    Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels

    Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.

    Product
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2024·2024-06-12

    Synchro SELECT Guidewires may have PTFE coating damage

    Stryker Neurovascular recalls certain lots of Synchro SELECT Guidewires due to PTFE coating damage that may occur when using a backloading technique. The damage is caused by sharper-than-intended edges on older introducer versions.

    Product
    The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2024·2024-06-12

    Stryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk

    Stryker Neurovascular is recalling certain lots of Synchro Neuro Guidewires due to PTFE coating damage that can occur when using a backloading technique with the optional introducer. Clinicians should avoid the backloading technique with affected product.

    Product
    The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2024·2024-06-05

    Synchro Guide Wires Recalled for Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.

    Product
    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2024·2024-06-05

    Stryker neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.

    Product
    Trevo ProVue, Catalog: 90184
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2024·2024-06-05

    Trevo NXT neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.

    Product
    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2024·2024-06-05

    FlowGate2 neurovascular devices may exceed endotoxin limits due to inadequate testing

    Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.

    Product
    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2024·2024-06-05

    Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination

    Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.

    Product
    Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1902-2024·2024-06-05

    Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing

    Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.

    Product
    Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2024·2024-06-05

    Neurovascular devices recalled due to inadequate endotoxin testing

    Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.

    Product
    DAC 044 115cm, Catalog: 90760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2024·2024-05-08

    Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination

    Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.

    Product
    The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2022·2022-07-27

    Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration

    Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.

    Product
    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0114-2021·2020-10-28

    Stryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture

    Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.

    Product
    Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M00
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1620-2020·2020-04-08

    Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk

    Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2020·2020-04-08

    Stryker AXS Vecta 74 Aspiration Catheter Recall for Potential Fracture

    Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

    Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.

    Product
    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0232-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.

    Product
    Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0226-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.

    Product
    Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0231-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0230-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error

    Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.

    Product
    Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide