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Terminated

WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

FDA Recall Z-2878-2018 · Posted None

Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeNGV
Date Initiated2018-05-07
Date Terminated2020-11-14
Product Quantity25 units

Reason for Recall

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.

Firm Action

Coherex Medical notified customers via "URGENT FIELD SAFETY NOTICE Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System (32 mm) Catalog No: WCR1523, Lot Number: All" letter dated May 7, 2018. The letter provided an overview, and important information about the product description and codes, lots subject to removal, why customers were being contacted, What actions are required/instructions, available assistance/contact information, and Reply Form.

Root Cause

Component design/selection

Distribution Pattern

No U.S. Distribution. International Distribution only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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