MICROVENTION INC.: Medical Device Recall in 2022 - (Recall #: Z-0170-2023)
See the recall detail below. You can also see other recalls from the same firm in 2022.
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Class II
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
REF/UDI/Lots: WDC-2/00842429103128/0000095683, 0000096284, 0000205967, 0000206629, 0000215962, 0000216862, 0000224074, 0000241662, 0000242343, 0000242345; Distributed in China: WDC/00842429113684/0000078840, 0000086571, 0000088347, 0000088349, 0000136477, 0000181460, 0000191147; Distribution in Japan: MV-WDC2/04987892122231/0000142172; 0000166445; 0000210109; 0000245337
Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Australia, South Korea, Italy, UK.
Voluntary: Firm initiated