The FDA has posted 6 enforcement recalls from Microvention INC. since 2025, none of them Class I (most serious). Most recent report: Aug 19, 2026.
Due to an increase rate of balloon pinhole defects.
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration.…
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…
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…
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Firm name as filed with the FDA: “MICROVENTION INC.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.