Recall Z-0170-2023 ยท OPR Intrasaccular Flow Disruption Device
MICROVENTION INC.
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
| Date | Nov 2, 2022 (initiated Sep 21, 2022) |
| Status | Open, Classified |
| 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. Custome |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.