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.

26–50 of 109

  • LowFDA (Devices)·Z-0225-2020·2019-11-06

    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, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, 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-0065-2020·2019-10-16

    Stryker Neurovascular Recalls 8F Balloon Guide Catheters Due to Packaging Error

    Stryker Neurovascular is recalling 190 8F Balloon Guide Catheters because they were incorrectly packaged in 9F Balloon Guide Catheter packaging. The affected lot was distributed only outside the United States.

    Product
    Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1708-2019·2019-06-12

    Stryker AXS Infinity LS Plus Long Sheath Recalled for Brittle Behavior

    Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.

    Product
    Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Lon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3281-2018·2018-10-10

    Stryker AXS Infinity LS Long Sheath Recalled for Specification Exceedance

    Stryker Neurovascular is recalling 15 units of the AXS Infinity LS Long Sheath because the dilator's outer diameter exceeded specifications.

    Product
    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-3020-2018·2018-09-19

    Stryker Wingspan Stent System Recalled for Coating Damage

    Stryker Neurovascular is recalling Wingspan Stent Systems because use-related coating damage was reported on the delivery catheter shafts.

    Product
    Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2569-2018·2018-08-08

    Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect

    Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.

    Product
    FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2018·2018-01-24

    Stryker Recalls Trevo XP ProVue System Due to Carton Mismatch

    Stryker Neurovascular is recalling one Trevo XP ProVue System kit because the carton sleeve did not match the physical contents of the pack.

    Product
    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0276-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0275-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0277-2018·2017-12-27

    Stryker Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific stroke intervention kits because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2802-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 48 Stroke Fast Packs because the pre-printed carton sleeve contents did not match the physical items inside.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2017·2017-08-09

    Stryker Stroke Fast Pack Recall Due to Mismatched Carton Sleeve Labeling

    Stryker Neurovascular is recalling 139 Stroke Fast Packs because the pre-printed contents on the carton sleeve did not match the physical contents of the pack.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2800-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2799-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 43 Stroke Fast Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0337-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0339-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0341-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0346-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0347-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.

    Product
    Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0342-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0333-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0344-2017·2016-11-09

    Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.

    Product
    Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0345-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states