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Microvention Inc. FDA Recalls
15 recalls on file across devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facClass IIApr 30, 2026Due to an increase rate of balloon pinhole defects. |
| LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mClass IIApr 6, 2026Stent-assisted coiling device may due to commingling during |
| Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551Class IISep 5, 2025Flow diverter may have a manufacturing issue related to the |
| LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400Class IIMay 29, 2025Drug Elutable Microspheres have a smaller actual average dia |
| MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297Class IIDec 11, 2024Potential for Polytetrafluoethylene (PTFE) material encasing |
| Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx OnClass IIDec 2, 2024Sterility assurance; microcatheter inner packaging may conta |
| ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy deviClass IIAug 5, 2024Due to Retrieval Device product labels stating the incorrect |
| TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600Class IIDec 21, 2023Due to, during the manufacturing process, the prescribed man |
| AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324Class IIAug 24, 2023Peripheral coil system detachable has a potential of unseale |
| FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352Class IIJun 7, 2023Intracranial aneurysm flow diverter device may be manufactur |
| WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.Class IISep 21, 2022Detachment controller, of an aneurysm embolization system, h |
| Aspiration Syringe Kit, REF: MVSK60Class IIOct 20, 2021Syringe Kits labeled for distribution OUS were inadvertently |
| VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a Class IIIApr 21, 2021Due to inadvertently shipping to U.S. customers with interna |
| VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a Class IIIApr 21, 2021Due to inadvertently shipping to U.S. customers with interna |
| VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a Class IIIApr 21, 2021Due to inadvertently shipping to U.S. customers with interna |