Recall Z-0170-2023— MICROVENTION INC.
Class II · Ongoing
Class II FDA medical device recall by MICROVENTION INC., initiated 2022-09-21. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- MICROVENTION INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-21
- Firm location
- Aliso Viejo, CA, United States
Product description
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.