Z-2878-2018Class I

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

Name: Z-2878-2018 WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523
Creator: Biosense Webster, Inc.
Published: 2018-05-07
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2018-05-07 / Terminated / root cause: design

FDA source

Biosense Webster, Inc. began a recall of WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523 on 2018-05-07. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2878-2018
Classification: Class I
Status: Terminated
Initiated: 2018-05-07
Posted: 2018-08-30
Terminated: 2020-11-14
Recalling firm: Biosense Webster Inc
Product: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Product code: NGV System, Appendage Closure, Left Atrial
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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 25 units
Distribution: No U.S. Distribution. International Distribution only.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2878-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2878-2018	Class I	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-30

Product code NGV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)