Stryker Neurovascular
Stryker Neurovascular holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 108 FDA device recalls on record.
Top product codes for Stryker Neurovascular
FDA recalls by Stryker Neurovascular
10 most recent of 108- Z-0021-2025 — 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 radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
- Z-1909-2024 — 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
- Z-1908-2024 — DAC 044 115cm, Catalog: 90760
- Z-1904-2024 — Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
- Z-1907-2024 — FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
- Z-1903-2024 — Trevo ProVue, Catalog: 90184
- Z-1905-2024 — 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-PACK - CE, Catalog: 91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190
- Z-1906-2024 — Trevo Trak 21 Microcatheter, Catalog: 90338
- Z-1902-2024 — 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, Catalog: 80052 TREVO XP 4X30+PRO18 2-PACK, Catalog: 93067 TREVO XP 6X25+XT27 2-PACK, Catalog: 93068 TREVO XP 3X20+PRO14+CAT6 3-PACK - CE, Catalog: M0033PK32021002 TREVO XP 4X20+PRO18+CAT6 3-PACK - CE, Catalog: M0033PK42022002 TREVO XP 6X25+XT27+CAT6 3-PACK - CE, Catalog: M0033PK62523002
- Z-1939-2024 — 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 procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker Neurovascular
- K261889 — Trevo Trak 21 Microcatheter
- K253032 — AXS Lift Intracranial Base Catheter
- K252694 — Target Detachable Coil
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
- K243593 — AXS Lift Intracranial Base Catheter
- K241637 — Echo Intracranial Base Catheter
- K241768 — Broadway 8 Catheter
- K223305 — Trevo NXT ProVue Retriever
- K222533 — Target Tetra Detachable Coils
- K211594 — Trevo Trak 21 Microcatheter
- K212455 — InZone Detachment System
- K202752 — AXS Vecta 46 Intermediate Catheter
- K210502 — Trevo NXT ProVue Retriever
- K203219 — Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever
- K202522 — Synchro SELECT Guidewire
- K200206 — AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
- K190833 — AXS Vecta Aspiration Catheter
- K193034 — AXS Infinity LS Plus Long Sheath
- K191768 — AXS Vecta Aspiration System
- K190212 — AXS Vecta Aspiration System
- K163259 — AXS Offset Delivery Assist Catheter
- K161429 — Target Detachable Coils
- K153658 — Target Detachable Coils
- K160096 — InZone Detachment System
- K142565 — Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
- K132542 — TRANSGATE GUIDE CATHETER
- K122576 — TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
- K123377 — TARGET DETACHABLE COIL
- K113778 — EXCELSIOR XT-27 MICROCATHETER
- K120850 — TARGET DETACHABLE COIL
- K113412 — TARGET DETACHABLE COIL
- K112385 — TRAGET DETACHABLE COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.