Microvention Recalls

38 recalls on record in the United States

medical: 38
medical Class II
2017-09-13

Microvention, Inc. recalls MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophil

There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

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medical Class II
2025-10-22

MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED501

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.

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medical Class II
2025-08-06

MICROVENTION INC. recalls LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers

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.

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medical Class II
2025-02-19

MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 2

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

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medical Class II
2025-01-29

MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter wi

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

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medical Class II
2024-09-25

MICROVENTION INC. recalls ERIC Retrieval Device REF: ER173020 ER174030 ER176044

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.

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medical Class II
2024-02-07

MICROVENTION INC. recalls TERUMO HydroPearl Compressible Microspheres for Embolisation

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

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medical Class II
2023-11-08

MICROVENTION INC. recalls AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, R

Peripheral coil system detachable has a potential of unsealed pouch packaging.

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medical Class II
2023-08-02

MICROVENTION INC. recalls FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

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medical Class II
2022-11-09

MICROVENTION INC. recalls WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Compon

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

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medical Class II
2021-11-10

MICROVENTION INC. recalls Aspiration Syringe Kit, REF: MVSK60

Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

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medical Class III
2021-06-16

MICROVENTION INC. recalls VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage:

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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medical Class III
2021-06-16

MICROVENTION INC. recalls VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage:

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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medical Class III
2021-06-16

MICROVENTION INC. recalls VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage:

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo HydroSoft 10, HydroCoil Embolic System,

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo HydroFrame 18, HydroCoil Embolic System,

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex, Platinum Coil System, Endovas

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo HydroFrame 10, HydroCoil Embolic System,

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Embolization Coil

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo HydroSoft 10, HydroCoil Embolic System,

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 18, Platinum Coil System, Endo

The devices may be missing the implant coil.

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medical Class II
2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

The devices may be missing the implant coil.

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Showing 30 of 38 recalls. See all →