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

Recall date

May 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2878-2018

FDA classification

Class I

Brand / firm

Biosense Webster, Inc.

Sold / distributed

No U.S. Distribution. International Distribution only.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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