Stryker Neurovascular

FDA Regulatory Profile

Summary

Total Recalls
108 (1 Class I)
510(k) Clearances
32
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0021-2025Class IIThe Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with rAugust 30, 2024
Z-1902-2024Class IITrevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 April 23, 2024
Z-1904-2024Class IITrevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238April 23, 2024
Z-1903-2024Class IITrevo ProVue, Catalog: 90184April 23, 2024
Z-1908-2024Class IIDAC 044 115cm, Catalog: 90760April 23, 2024
Z-1906-2024Class IITrevo Trak 21 Microcatheter, Catalog: 90338April 23, 2024
Z-1905-2024Class IITrevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91April 23, 2024
Z-1907-2024Class IIFlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495April 23, 2024
Z-1909-2024Class IISynchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, CataApril 23, 2024
Z-1939-2024Class IIThe Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diamApril 18, 2024
Z-1940-2024Class IIThe Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are availabApril 18, 2024
Z-1941-2024Class IIThe Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in sApril 18, 2024
Z-1740-2024Class IIThe Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopApril 3, 2024
Z-1386-2022Class IITrevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXJune 3, 2022
Z-0114-2021Class ITrevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). September 21, 2020
Z-1708-2019Class IIStryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 8April 18, 2019
Z-1620-2020Class IIStryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021April 10, 2019
Z-1621-2020Class IIStryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021April 10, 2019
Z-0065-2020Class IIStryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 9November 13, 2018
Z-0230-2020Class IISynchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M0June 8, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K253032AXS Lift Intracranial Base CatheterFebruary 11, 2026
K252694Target Detachable CoilDecember 11, 2025
K251832InZone IST Detachment System; IZDS Connecting CableOctober 17, 2025
K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped MicrocMarch 21, 2025
K243593AXS Lift Intracranial Base CatheterFebruary 18, 2025
K241637Echo Intracranial Base CatheterDecember 19, 2024
K241768Broadway 8 CatheterDecember 19, 2024
K223305Trevo NXT ProVue RetrieverMarch 29, 2023
K222533Target Tetra Detachable CoilsDecember 14, 2022
K211594Trevo Trak 21 MicrocatheterNovember 26, 2021
K212455InZone Detachment SystemNovember 16, 2021
K210502Trevo NXT ProVue RetrieverAugust 27, 2021
K202752AXS Vecta 46 Intermediate CatheterAugust 27, 2021
K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverDecember 29, 2020
K202522Synchro SELECT GuidewireSeptember 25, 2020
K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterFebruary 27, 2020
K190833AXS Vecta Aspiration CatheterDecember 15, 2019
K193034AXS Infinity LS Plus Long SheathNovember 29, 2019
K191768AXS Vecta Aspiration SystemJuly 30, 2019
K190212AXS Vecta Aspiration SystemApril 24, 2019