Reported Nov 9, 2022 · Ongoing
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Microvention Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- WEB Detachment Controller
- REFWDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System
- Lot codes and dates
- REF/UDI/Lots
WDC-2/00842429103128/0000095683000009628400002059670000206629000021596200002168620000224074000024166200002423430000242345
- Distributed in China
WDC/00842429113684/0000078840000008657100000883470000088349000013647700001814600000191147
- Distribution in Japan
MV-WDC2/04987892122231/0000142172000016644500002101090000245337
- REF/UDI/Lots
- Amount recalled
- 2018
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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