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U.S. Department of Health and Human Services

Class 2 Device Recall WEB Detachment Controller

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  Class 2 Device Recall WEB Detachment Controller see related information
Date Initiated by Firm September 21, 2022
Date Posted November 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-0170-2023
Recall Event ID 90966
PMA Number P170032 
Product Classification Intrasaccular Flow Disruption Device - Product Code OPR
Product WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Code Information 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
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information Contact
714-247-8159
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OPR and Original Applicant = MicroVention, Inc.
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