Home › Device types › NGV
System, Appendage Closure, Left Atrial
FDA product code NGV · Class 3 · Unknown
33
Registered devices
17,168
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
WATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONAmplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.WATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN® — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN® Access System — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ Pro — BOSTON SCIENTIFIC CORPORATIONAmplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.WATCHMAN® Access System — BOSTON SCIENTIFIC CORPORATIONWATCHMAN FLX™ — BOSTON SCIENTIFIC CORPORATIONAmplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC.WATCHMAN® — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-07 | Biosense Webster, Inc. | When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or fail |
| 2015-08-25 | Boston Scientific Corporation | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired |
| 2015-08-25 | Boston Scientific Corporation | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired |
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