Recall database

Device, Vascular, For Promoting Embolization recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

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-1989-2025

BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT…

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

BALT USA, LLCCAJun 25, 2025

Class IIOngoingZ-1762-2025

Cook Incorporated recalls Tornado Embolization Microcoil

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

Cook IncorporatedINMay 21, 2025