The Recall Desk

Manufacturer

Microvention, Inc.

38 recalls in our database name Microvention, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
38
Critical
0
Severe
3
Most recent
2026-08-19

Of the 38 recalls from Microvention, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 38

  • HighFDA (Devices)·Z-2912-2026·2026-08-19

    Microvention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects

    Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.

    Product
    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 the peripheral and neurovascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2200-2026·2026-05-20

    LVIS Intraluminal Support Device Stent Recalled Dimensional Nonconformance

    MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

    MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.

    Product
    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, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2025·2025-08-06

    LIFEPEARL microspheres are smaller than specification, risking non-targeted embolization

    LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.

    Product
    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1121-2025·2025-02-19

    LVIS Intraluminal Support Device May Fail to Deploy Properly

    MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.

    Product
    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 providing support to the embolic coils used in the treatment of
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0990-2025·2025-01-29

    Microvention Headway Microcatheter Recall Due to Incomplete Packaging Seal

    Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.

    Product
    Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3157-2024·2024-09-25

    Medical Thrombectomy Device Recalled for Incorrect Expiration Dates

    MicroVention is recalling 1,370 ERIC Retrieval Devices due to labeling errors showing incorrect expiration dates (5 years instead of actual 3 years). Devices with mislabeled shelf life may be used beyond their true expiration.

    Product
    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 patients suffering from acute ischemic stroke.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2024·2024-02-07

    TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation

    MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.

    Product
    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2024·2023-11-08

    AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging

    MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.

    Product
    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    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, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2023·2022-11-09

    Aneurysm Embolization System Detachment Controller Recalled for Manufacturing Defect

    MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.

    Product
    WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2022·2021-11-10

    Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling

    MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.

    Product
    Aspiration Syringe Kit, REF: MVSK60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2021·2021-06-16

    VIA Microcatheter shipped with incorrect international labeling instead of US labels

    MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2021·2021-06-16

    VIA Microcatheter VIA 21 Recalled for International Labeling Error

    MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1828-2021·2021-06-16

    VIA Microcatheter recalled due to incorrect international labeling shipped to US

    MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1402-2020·2020-03-04

    MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.

    Product
    MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HF
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1395-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    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, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1406-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 666 units of Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC1520
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1394-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 486 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1393-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 1,725 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1404-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coils

    MicroVention is recalling 85 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    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-V, and 100721CMSR-V. Product Usage: The MCS is also inten
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1399-2020·2020-03-04

    MicroVention Platinum Embolization Coils Recalled for Missing Implant Coil

    MicroVention is recalling 403 units of Platinum Embolization Coils because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Produc
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2020·2020-03-04

    MicroVention HydroSoft 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 2,762 units of HydroSoft 10 embolic coils because the implant coil may be missing from the packaging.

    Product
    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-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V;
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1403-2020·2020-03-04

    MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil

    MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.

    Product
    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. Product Usage: The HES is also intended for vascular occlu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1397-2020·2020-03-04

    MicroVention Platinum Coil System Recall for Missing Implant Coils

    MicroVention is recalling 169 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    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: The MCS is also intended for vascular occlusion of blood v
    Category
    Medical Device
    Distribution
    1 state