--- title: "Stryker Neurovascular Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Stryker Neurovascular recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/stryker-neurovascular/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Stryker Neurovascular recall records **15** reported ongoing 15 records in this archive. Latest source date Apr 6, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 6, 2026 FDA device enforcement ### [INZONE DETACHMENT SYSTEM, REF: M00345100950](https://isitonrecall.com/recall/fda-device-z-2552-2026-inzone-detachment-system-ref-m00345100950/) Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical interventi... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC,... [Official source for INZONE DETACHMENT SYSTEM, REF: M00345100950](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2552-2026%22) Aug 30, 2024 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-0021-2025-the-trevo-trak-21-microcatheter-is-a-single-lumen-braided-shaft-variable-stiffness-catheter-with-rad/) Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA and VA. [Official source for The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter wit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0021-2025%22) Apr 23, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-1902-2024-trevo-xp-provue-retriever-4-x-20-catalog-90182-trevo-xp-provue-retriever-3-x-20-catalog-90183-trevo/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1902-2024%22) Apr 23, 2024 FDA device enforcement ### [Trevo ProVue, Catalog: 90184](https://isitonrecall.com/recall/fda-device-z-1903-2024-trevo-provue-catalog-90184/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Trevo ProVue, Catalog: 90184](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1903-2024%22) Apr 23, 2024 FDA device enforcement ### [Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238](https://isitonrecall.com/recall/fda-device-z-1904-2024-trevo-pro-14-microcatheter-catalog-90231-trevo-pro-18-microcatheter-catalog-90238/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1904-2024%22) Apr 23, 2024 FDA device enforcement ### [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-PAC...](https://isitonrecall.com/recall/fda-device-z-1905-2024-trevo-nxt-provue-3-x-32-us-catalog-90312-kits-trevo-nxt-3x32-trak21-2-pack-ce-catalog-91412-trevo-nx/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 914...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1905-2024%22) Apr 23, 2024 FDA device enforcement ### [Trevo Trak 21 Microcatheter, Catalog: 90338](https://isitonrecall.com/recall/fda-device-z-1906-2024-trevo-trak-21-microcatheter-catalog-90338/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Trevo Trak 21 Microcatheter, Catalog: 90338](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1906-2024%22) Apr 23, 2024 FDA device enforcement ### [FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495](https://isitonrecall.com/recall/fda-device-z-1907-2024-flowgate2-8f-x-85cm-catalog-90485-flowgate2-8f-x-95cm-catalog-90495/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1907-2024%22) Apr 23, 2024 FDA device enforcement ### [DAC 044 115cm, Catalog: 90760](https://isitonrecall.com/recall/fda-device-z-1908-2024-dac-044-115cm-catalog-90760/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for DAC 044 115cm, Catalog: 90760](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1908-2024%22) Apr 23, 2024 FDA device enforcement ### [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 SYNCH...](https://isitonrecall.com/recall/fda-device-z-1909-2024-synchro-014-guide-wire-35-cm-tip-catalog-m00313010-synchro-014-guide-wire-300-cm-length-catalog-m003/) 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 level... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA,... [Official source for Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Ca...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1909-2024%22) Apr 18, 2024 FDA device enforcement ### [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 Sync...](https://isitonrecall.com/recall/fda-device-z-1939-2024-the-synchro-neuro-guidewires-are-a-steerable-guidewire-family-with-a-shapeable-tip-the-outside-diame/) Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ,... [Official source for The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside d...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1939-2024%22) Apr 18, 2024 FDA device enforcement ### [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 guidewire...](https://isitonrecall.com/recall/fda-device-z-1940-2024-the-synchro-select-guidewires-are-a-steerable-guidewire-family-with-a-shapeable-tip-and-are-availabl/) Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ,... [Official source for The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are avail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1940-2024%22) Apr 18, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-1941-2024-the-synchro2-guidewires-are-a-steerable-guidewire-family-with-a-shapeable-tip-and-are-available-in-s/) Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ,... [Official source for The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available i...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1941-2024%22) Apr 3, 2024 FDA device enforcement ### [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 cathete...](https://isitonrecall.com/recall/fda-device-z-1740-2024-the-distal-access-catheter-is-a-single-lumen-braided-shaft-variable-stiffness-catheter-with-radiopaq/) Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL. [Official source for The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with rad...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1740-2024%22) Jun 3, 2022 FDA device enforcement ### [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: 91...](https://isitonrecall.com/recall/fda-device-z-1386-2022-trevo-trak-21-microcatheter-ref-90338-trevo-nxt-3x32-trak21-2-pack-ce-ref-91412-trevo-nxt-4x28-trak2/) Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT. [Official source for Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1386-2022%22) ## Reasons in these listed records - Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure ... - Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. - 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 ... - Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro ... These examples come from this result page and are not a ranking of every recall reason. ## Checking Stryker Neurovascular ### Is there a recall on stryker neurovascular right now? This archive contains 15 records, including 15 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Stryker Neurovascular](https://isitonrecall.com/check/?q=Stryker%20Neurovascular) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)