Z-0170-2023Class II

WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System

Name: Z-0170-2023 WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System
Creator: Microvention Inc.
Published: 2022-09-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2022-09-21 / Open, Classified / root cause: manufacturing process

FDA source

MICROVENTION INC. began a recall of WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System on 2022-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0170-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-21
Posted: 2022-11-02
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Product code: OPR Intrasaccular Flow Disruption Device
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
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-02

Product code OPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)