System, Appendage Closure, Left Atrial
FDA product code NGV · Class III (high risk) · Cardiovascular
0510(k) clearances
2PMA approvals
3recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2878-2018 Class I | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523…When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting… | Biosense Webster, Inc. | 05/07/2018Terminated |
| Z-2766-2015 Class II | Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve(…Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly… | Boston Scientific Corporation | 08/25/2015Terminated |
| Z-2765-2015 Class II | Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System…Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly… | Boston Scientific Corporation | 08/25/2015Terminated |