Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Neurology · 21 CFR 882.5600
A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Recent MDR events
96 adverse event reports on file
- TREVO NXT 6MM X 37MM - CEJul 20, 2026MalfunctionStryker Neurovascular-utah-salt Lake City3012931345-2026-00116
- TREVO NXT 4MM X 41MM - CEJul 13, 2026MalfunctionStryker Neurovascular-utah-salt Lake City3012931345-2026-00110
- TREVO NXT 4MM X 28MM - USMay 22, 2026InjuryStryker Neurovascular-utah-salt Lake City3012931345-2026-00094
- TREVO NXT 3MM X 32MM - USMar 26, 2026InjuryStryker Neurovascular-utah-salt Lake City3012931345-2026-00063
- TREVO NXT 6MM X 37MM - CEMar 19, 2026MalfunctionStryker Neurovascular-utah-salt Lake City3012931345-2026-00050
- SOLITAIRE INTRODUCER SHEATHMar 2, 2026InjuryMicro Therapeutics, Inc. Dba Ev3 NeurovascularMW5184592
- TREVO NXT 4MM X 41MM - CEFeb 18, 2026MalfunctionStryker Neurovascular-utah-salt Lake City3012931345-2026-00034
- SOLITAIRE¿ XFeb 6, 2026MalfunctionMicro Therapeutics, Inc.24277579
- TREVO NXT 6MM X 37MM - CEDec 22, 2025InjuryStryker Neurovascular-utah-salt Lake City3012931345-2025-00200
- TREVO NXT 3MM X 32MM - USDec 3, 2025MalfunctionStryker Neurovascular-utah-salt Lake City3012931345-2025-00190
Event type breakdown
Recalls
3 recall events for this product code
- Stryker NeurovascularOpen, ClassifiedMay 28, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Z-1902-2024 · View FDA record ↗ - Stryker NeurovascularOpen, ClassifiedMay 28, 2024
Trevo NXT ProVue 3 x 32, US, Catalog: 90312
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Z-1905-2024 · View FDA record ↗ - Stryker NeurovascularTerminatedOct 21, 2020
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, M0
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
Z-0114-2021 · View FDA record ↗
Registered firms
39 firms currently registered for this product code
Medtronic Distribution Center
Memphis, TN, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Stryker Neurovascular
Salt Lake City, UT, US
Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Irvine, CA, US
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Irvine, CA, US
Phenox Limited
Galway, IE
Covidien Medical Products (shanghai) Manufacturing Llc
Shanghai, CN
Stryker Us Supply Chain Operations
Plainfield, IN, US
Neurovasc Technologies, Inc.
Irvine, CA, US
Stryker Neurovascular
Fremont, CA, US
Gravity Medical Technology
Lake Forest, CA, US
510(k) clearances
18 clearances for this product code
- Phenox LimitedFeb 28, 2025
K242676 · pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
- Phenox LimitedOct 21, 2023
K231539 · pRESET LITE Thrombectomy Device
- Stryker NeurovascularMar 29, 2023
K223305 · Trevo NXT ProVue Retriever
- Phenox LimitedJan 20, 2023
K222848 · pRESET Thrombectomy Device
- Stryker NeurovascularAug 27, 2021
K210502 · Trevo NXT ProVue Retriever
- Micro Therapeutics, Inc. d/b/a ev3 NeurovascularMar 1, 2021
K203358 · Solitaire X Revascularization Device
- Stryker NeurovascularDec 29, 2020
K203219 · Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever
- Micro Therapeutics, Inc. d/b/a ev3 NeurovascularNov 20, 2020
K193576 · Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)