Biosense Webster, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2878-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 7, 2018

Date Posted: September 5, 2018

Recall Number: Z-2878-2018

Event ID: 80720

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.

Status: Terminated

Product Quantity: 25 units

Code Information:

All lots.

Distribution Pattern:

No U.S. Distribution. International Distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated