Microvention recalls WEB Detachment Controller (WDC-2) due to potential implant misplacement during aneurysm embolization. Affected units have specific serial numbers sold in China and Japan. Contact for remedy.
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
Microvention is recalling its WEB Detachment Controller (model WDC-2) because a manufacturing defect may cause the implant device to move and damage blood vessels during surgery. This could lead to serious complications if the implant is not properly detached.
The detachment controller has an incorrect tunnel opening dimension that may prevent the implant pusher from fully inserting. This could cause the implant to move during detachment, potentially damaging blood vessels.
Surgical teams using the WEB Aneurysm Embolization System in China and Japan are likely affected. Patients undergoing procedures with this specific controller model are at risk of vessel damage.
Check for serial numbers WDC-2/00842429103128, 0000095683, 0000096284, 0000205967, 0000206629, 0000215962, 0000216862, 0000224074, 0000241662, 0000242343, 0000242345 in China and Japan. The product is part of the WEB Aneurysm Embolization System.
Verify if your WEB Detachment Controller has the listed serial numbers from the recall notice.
The detachment controller has an out of specification tunnel opening dimension that may prevent the implant device from being fully inserted, risking vessel damage during surgery.
The recall notice does not specify a remedy. Contact Microvention directly for guidance.
The product was distributed in China and Japan with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-0170-2023 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-0170-2023 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.