FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
- Recall number
- Z-0170-2023
- Recalling firm
- MICROVENTION INC.
- Product
- WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
- Status
- Open, Classified
- Initiated
- 2022-09-21
- Posted
- 2022-11-02
- Terminated
- not on file
- 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
- Root cause
- Process control
- Action
- On 09/21/2022, recall notices were mailed to customers who were asked to do the following: 1) Identify, quarantine, and return all impacted devices. 2) Complete and return Customer Acknowledgment and Device Reconciliation form the recall instructions provided in the letter and have shared this notification with all device users within my facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred. Complete and return the acknowledgement and receipt form. Customers with additional questions can call the recalling firm at 949-501-0355, Monday - Friday PST 8:00 - 5:00 pm or email customerservice@microvention.com
- Quantity
- 2018
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P170032"]
- Product code
- OPR
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28