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WATCHMAN FLX™ Pro
BOSTON SCIENTIFIC CORPORATION · Model M635WU60270 · UDI-DI 00191506004606
NGV
Prescription
0
510(k) clearances
17,168
Adverse events (1,816 deaths)
3
Recalls
17
Facilities
Description
Left Atrial Appendage Closure Device with Delivery System
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 failure to recapture the |
| 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. This Field Correct |
| 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. This Field Correct |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.