FDASeptember 21, 2022device
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Ongoing
Brands named
microvention
UPCs
008424291031280084242911368404987892122231
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALVIS 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 mm2026-04-06
- FDAFlow 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, FREDX5522-PMA, FRE...2025-09-05
- FDALIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S4002025-05-29
- FDAMicoVention 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 wide-necked aneury...2024-12-11
- FDAMicrovention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 00006298462024-12-02
- FDAERIC 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.2024-08-05
- FDATERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S6002023-12-21
- FDAAZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-7513242023-08-24
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