WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. — FDA record Z-0170-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Reason
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
Classification
Class II
Recalling firm
MICROVENTION INC.
Quantity
2018
Agency-reported status
Ongoing
Source record identifier
Z-0170-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityREF/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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Nov 9, 2022
Recall initiation date
Sep 21, 2022
Center classification date
Nov 2, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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