Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2878-2018 — WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

U.S. FDA — Device Enforcement · United States · 2018-05-07 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2878-2018
Date of alert
2018-05-07
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Biosense Webster, Inc.
Product category
device
Product type
Devices
Reported risk: 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 device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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