FDA recall Z-2878-2018

Product

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

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.

Distribution

No U.S. Distribution. International Distribution only.

Key facts

Status

Terminated

Initiation date

2018-05-07

Report date

2018-09-05

Termination date

2020-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irwindale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2878-2018