fda
26 records
FDA Recall: MICROVENTION INC. — Class II
20260520
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If de | Product: LVIS Intraluminal Support Device, REF/...
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FDA Device Recall: MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 m
2025-02-19
Class II — Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
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FDA Device Recall: Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coati
2025-01-29
Class II — Sterility assurance; microcatheter inner packaging may contain incomplete seal.
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FDA Device Recall: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
2023-11-08
Class II — Peripheral coil system detachable has a potential of unsealed pouch packaging.
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FDA Device Recall: FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511
2023-08-02
Class II — Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
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FDA Device Recall: WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm
2022-11-09
Class II — 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 t...
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FDA Device Recall: VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen ca
2021-06-16
Class III — Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
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FDA Device Recall: VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen ca
2021-06-16
Class III — Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
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FDA Recall: Microvention, Inc. — Class II
20200304
The devices may be missing the implant coil. | Product: MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical,
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FDA Recall: Microvention, Inc. — Class II
20200304
The devices may be missing the implant coil. | Product: MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18,
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FDA Recall: Microvention, Inc. — Class II
20200304
The devices may be missing the implant coil. | Product: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10,
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FDA Recall: Microvention, Inc. — Class II
20200304
The devices may be missing the implant coil. | Product: MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 S
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FDA Recall: Microvention, Inc. — Class II
20200219
The devices may be missing the implant coil. | Product: Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-
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FDA Device Recall: MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Emboliz
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emboli
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolizatio
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization C
2020-03-04
Class II — The devices may be missing the implant coil.
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FDA Device Recall: Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-75
2020-02-19
Class II — The devices may be missing the implant coil.
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FDA Device Recall: Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-
2020-02-19
Class II — The devices may be missing the implant coil.
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FDA Device Recall: Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolizatio
2020-02-19
Class II — The devices may be missing the implant coil.
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FDA Device Recall: MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW07
2017-09-13
Class II — There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
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