Z-0170-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2018
Product Description
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Reason for Recall
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
Distribution Pattern
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.
Code Information
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