MICROVENTION INC.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for MICROVENTION INC. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-22FDA-DeviceClass IIFlow 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, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X
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 necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
- 2025-08-06FDA-DeviceClass IILIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
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/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
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