Aliso Viejo, CA, United States
Microvention, Inc. recalls
15 recalls recorded since 2018, most recently on 30 April 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)11
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Due to an increase rate of balloon pinhole defects.
- 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 countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherla
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2912-2026
- 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 into a selected blood vessel in th
Ongoing Class II Medical devices
- Recall started
- 6 April 2026
- Reason
- 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 lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- Distribution
- International distribution to the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2200-2026
- 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/3.5 mm x 17 mm x 13 mm
Ongoing Class II Medical devices
- Recall started
- 5 September 2025
- Reason
- 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 system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
- 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, KR, SK, MX, DK, IR, SA, BY, PA, VN, ZA, BR, TW, CN, BE, FR, VE, MY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0108-2026
- Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE
Ongoing Class II Medical devices
- Recall started
- 29 May 2025
- Reason
- 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, increased procedure time, incomplete embolization, and/or inability to treat the patient.
- Distribution
- OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2188-2025
- LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Ongoing Class II Medical devices
- Recall started
- 11 December 2024
- Reason
- Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- Distribution
- US: None OUS: China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1121-2025
- 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 a stent-assisted coiling (SAC) device prov
Ongoing Class II Medical devices
- Recall started
- 2 December 2024
- Reason
- Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- Distribution
- US: None OUS: China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0990-2025
- Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Ongoing Class II Medical devices
- Recall started
- 5 August 2024
- Reason
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3157-2024
- 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 from occlusive vasculature in patien
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
- Distribution
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0868-2024
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Ongoing Class II Medical devices
- Recall started
- 24 August 2023
- Reason
- Peripheral coil system detachable has a potential of unsealed pouch packaging.
- Distribution
- US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0187-2024
- AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Ongoing Class II Medical devices
- Recall started
- 7 June 2023
- Reason
- Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
- 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 and the countries of Taiwan, Chile, India, South Korea, Malaysia, Canada, France, Morocco, Belgium, Spain, Turkey, Poland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2238-2023
- 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, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FR
Ongoing Class II Medical devices
- Recall started
- 21 September 2022
- Reason
- 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 to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
- 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, Australia, South Korea, Italy, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0170-2023
- WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Terminated Class II Medical devices
- Recall started
- 20 October 2021
- Terminated
- 15 May 2024
- Reason
- Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
- Distribution
- US Nationwide distribution in the states of AL, NY, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0202-2022
- Aspiration Syringe Kit, REF: MVSK60
Terminated Class III Medical devices
- Recall started
- 21 April 2021
- Terminated
- 16 February 2024
- Reason
- Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
- Distribution
- U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1829-2021, Z-1828-2021, Z-1830-2021
- VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
- VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
- VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Terminated Class II Medical devices
- Recall started
- 24 November 2019
- Terminated
- 20 April 2021
- Reason
- The devices may be missing the implant coil.
- Distribution
- The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1225-2020, Z-1221-2020, Z-1220-2020, Z-1223-2020, Z-1222-2020, Z-1224-2020
- Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50
- Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Ter
- Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-48031
- Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-4504
- Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45
- Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation
Terminated Class II Medical devices
- Recall started
- 22 November 2019
- Terminated
- 26 January 2022
- Reason
- The devices may be missing the implant coil.
- Distribution
- All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1392-2020, Z-1401-2020, Z-1404-2020, Z-1397-2020, Z-1403-2020, Z-1407-2020, Z-1395-2020, Z-1400-2020, Z-1406-2020, Z-1394-2020, Z-1398-2020, Z-1402-2020 and 4 more
- MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS
- MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is al
- MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-
- MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage
- MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA.
- MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100
- MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V
- MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V,
- and 8 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.