MICROVENTION INC.

5 FDA enforcement actions

5 Total Recalls

0 Class I

5 Class II

0 Class III

Firm Details

Product Types: device
States: CA

All Recalls

Class II: Risk 09/05/2025 device

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.
Class II: Risk 05/29/2025 device

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.
Class II: Risk 12/11/2024 device

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Class II: Risk 12/02/2024 device

Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Class II: Risk 08/05/2024 device

Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.