--- title: "MICROVENTION INC. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search MICROVENTION INC. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/microvention-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # MICROVENTION INC. recall records **11** reported ongoing 12 records in this archive. Latest source date Apr 30, 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 30, 2026 FDA device enforcement ### [BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter ...](https://isitonrecall.com/recall/fda-device-z-2912-2026-bobby-balloon-guide-catheter-ref-bob-895-cn-bob-895-emea-bob-895-emea-al-bob-895-us-mv-bga01095-for/) Due to an increase rate of balloon pinhole defects. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countri... [Official source for BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2912-2026%22) Apr 6, 2026 FDA device enforcement ### [LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/...](https://isitonrecall.com/recall/fda-device-z-2200-2026-lvis-intraluminal-support-device-ref-outside-diameter-od-xtotal-length-tl-xworking-length-wl-214022/) Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; ... Class II Reported ongoing Distribution: International distribution to the country of China. [Official source for LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 2...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2200-2026%22) Sep 5, 2025 FDA device enforcement ### [Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FR...](https://isitonrecall.com/recall/fda-device-z-0108-2026-flow-re-direction-endoluminal-devices-fred-27-ref-fred5019-fred5029-fred4528-fred4026-fred5526-fred4/) Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdraw... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, K... [Official source for Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0108-2026%22) May 29, 2025 FDA device enforcement ### [LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400](https://isitonrecall.com/recall/fda-device-z-2188-2025-lifepearl-drug-elutable-microspheres-200-50-micrometers-ref-8lp2s200-400-50-micrometers-ref-8lp2s400/) Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than... Class II Reported ongoing Distribution: OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russia... [Official source for LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micromete...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2188-2025%22) Dec 11, 2024 FDA device enforcement ### [MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as ...](https://isitonrecall.com/recall/fda-device-z-1121-2025-micovention-terumo-lvis-intraluminal-support-device-ref-213522-cas-od-3-5-mm-tl-22-mm-wl-18-mm-steri/) Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. Class II Reported ongoing Distribution: US: None OUS: China [Official source for MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1121-2025%22) Dec 2, 2024 FDA device enforcement ### [Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846](https://isitonrecall.com/recall/fda-device-z-0990-2025-microvention-headway-17-advanced-straight-microcatheter-with-hydrophilic-coating-ref-mc172150sx-cn-s/) Sterility assurance; microcatheter inner packaging may contain incomplete seal. Class II Reported ongoing Distribution: US: None OUS: China [Official source for Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0990-2025%22) Aug 5, 2024 FDA device enforcement ### [ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots ...](https://isitonrecall.com/recall/fda-device-z-3157-2024-eric-retrieval-device-ref-er173020-er174030-er176044-the-eric-retrieval-device-is-a-mechanical-throm/) Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA. [Official source for ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical t...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3157-2024%22) Dec 21, 2023 FDA device enforcement ### [TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600](https://isitonrecall.com/recall/fda-device-z-0868-2024-terumo-hydropearl-compressible-microspheres-for-embolisation-ref-8hp2s600/) Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI. [Official source for TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0868-2024%22) Aug 24, 2023 FDA device enforcement ### [AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324](https://isitonrecall.com/recall/fda-device-z-0187-2024-azur-cx-35-peripheral-coil-system-detachable-13mm-x-24-cm-ref-45-751324/) Peripheral coil system detachable has a potential of unsealed pouch packaging. Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA. [Official source for AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0187-2024%22) Jun 7, 2023 FDA device enforcement ### [FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, ...](https://isitonrecall.com/recall/fda-device-z-2238-2023-fred-flow-re-direction-endoluminal-device-ref-fred3507-pma-fred3511-fred3511-pma-fred3516-ca-fred351/) Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS ... [Official source for FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2238-2023%22) Sep 21, 2022 FDA device enforcement ### [WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.](https://isitonrecall.com/recall/fda-device-z-0170-2023-web-detachment-controller-ref-wdc-2-wdc-mv-wdc2-component-of-web-aneurysm-embolization-system/) Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller t... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Aust... [Official source for WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0170-2023%22) Oct 20, 2021 FDA device enforcement ### [Aspiration Syringe Kit, REF: MVSK60](https://isitonrecall.com/recall/fda-device-z-0202-2022-aspiration-syringe-kit-ref-mvsk60/) Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. Class II Reported terminated Distribution: US Nationwide distribution in the states of AL, NY, NV. [Official source for Aspiration Syringe Kit, REF: MVSK60](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0202-2022%22) ## Reasons in these listed records - Due to an increase rate of balloon pinhole defects. - Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may le... - Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery s... - Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, incr... These examples come from this result page and are not a ranking of every recall reason. ## Checking MICROVENTION INC. ### Is there a recall on microvention inc. right now? This archive contains 12 records, including 11 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 MICROVENTION INC.](https://isitonrecall.com/check/?q=MICROVENTION%20INC.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)