MICROVENTION Recalls
38 recalls on record · September 13, 2017 to August 19, 2026 · Medical Devices
Recalls by year
17
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026Medical DevicesFDA
MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in fac
Hazard: Due to an increase rate of balloon pinhole defects.
May 20, 2026Medical DevicesFDA
MICROVENTION INC. recalls LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m
Hazard: 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
October 22, 2025Medical DevicesFDA
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551
Hazard: 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.
August 6, 2025Medical DevicesFDA
MICROVENTION INC. recalls LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Hazard: 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.
February 19, 2025Medical DevicesFDA
MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297
Hazard: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
January 29, 2025Medical DevicesFDA
MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On
Hazard: Sterility assurance; microcatheter inner packaging may contain incomplete seal.
September 25, 2024Medical DevicesFDA
MICROVENTION INC. recalls ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi
Hazard: 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.
February 7, 2024Medical DevicesFDA
MICROVENTION INC. recalls TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Hazard: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
November 8, 2023Medical DevicesFDA
MICROVENTION INC. recalls AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Hazard: Peripheral coil system detachable has a potential of unsealed pouch packaging.
August 2, 2023Medical DevicesFDA
MICROVENTION INC. recalls FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352
Hazard: Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
November 9, 2022Medical DevicesFDA
MICROVENTION INC. recalls WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Hazard: 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
November 10, 2021Medical DevicesFDA
MICROVENTION INC. recalls Aspiration Syringe Kit, REF: MVSK60
Hazard: Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
June 16, 2021Medical DevicesFDA
MICROVENTION INC. recalls VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a
Hazard: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
June 16, 2021Medical DevicesFDA
MICROVENTION INC. recalls VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a
Hazard: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
June 16, 2021Medical DevicesFDA
MICROVENTION INC. recalls VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a
Hazard: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx,
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, R
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF num
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 18
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 10
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF num
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF num
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numb
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, RE
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx,
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, RE
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx,
Hazard: The devices may be missing the implant coil.
March 4, 2020Medical DevicesFDA
Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF n
Hazard: The devices may be missing the implant coil.