Class IIOngoingZ-2912-2026
MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-…
Due to an increase rate of balloon pinhole defects.
MICROVENTION INC.CAAug 19, 2026
MICROVENTION INC. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–6 of 6 recalls
Class IIOngoingZ-2200-2026
MICROVENTION INC. recalls LVIS Intraluminal Support Device
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration.…
MICROVENTION INC.CAMay 20, 2026
Class IIOngoingZ-0108-2026
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27
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 nece…
MICROVENTION INC.CAOct 22, 2025
Class IIOngoingZ-2188-2025
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/tr…
MICROVENTION INC.CAAug 6, 2025
Class IIOngoingZ-1121-2025
MICROVENTION INC. recalls MicoVention Terumo
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
MICROVENTION INC.CAFeb 19, 2025
Class IIOngoingZ-0990-2025
MICROVENTION INC. recalls Microvention
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
MICROVENTION INC.CAJan 29, 2025