Use cautionMedical device recall · FDA · Published May 7, 2018
Biosense Webster WaveCrest LAA 32mm Device Recall: Risk of Device Failure During Recapture
Biosense Webster recalls WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523, WCR2523) due to risk of device failure during recapture attempts.
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.
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Contact the company
📍Recalling firmBiosense Webster, Inc.15715 Arrow Hwy · Irwindale, CA 91706-2006
✎ GovInfoNow plain-language explainer
Biosense Webster is recalling WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523 and WCR2523) because the device may fold or buckle during recapture attempts, causing increased retraction force and potential failure to properly secure the device. Read more at govinfonow.com/recall/71173-biosense-webster-wavecrest-laa-32mm-device-recall-risk-of-device.
“Biosense Webster WaveCrest LAA 32mm Device Recall: Risk of Device Failure During Recapture.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71173-biosense-webster-wavecrest-laa-32mm-device-recall-risk-of-device. Based on FDA recall #Z-2878-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2878-2018%22&limit=1).
Biosense Webster, Inc. voluntarily recalled WaveCrest Left Atrial Appendage (LAA) Occlusion Systems (32 mm) with catalog numbers WCR1523 and WCR2523 on May 7, 2018, according to the FDA. The device may fail to recapture due to a folding delivery sheath tip.
How to tell if you have it
Brand: Biosense Webster
Product: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm)
Catalog numbers: WCR1523 and WCR2523
Lots: All lots
Quantity: 25 units
The hazard
When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle. This results in increased retraction force and difficulty or failure to recapture the device.
Context
GovInfoNow's records show Biosense Webster, Inc. has had 7 other recalls since June 14, 2017. Recent brand recalls include a VARIPULSE Catheter recall on Jan. 5, 2025, and a CARTO VIZIGO Bi-Directional Guiding Sheath recall on Feb. 16, 2024. Other recent recalls of similar products include Hologic SELENIA Dimensions Mammography Systems Recall (April 8, 2026) and Merit Medical Allwell Angioplasty Pack Recall (Dec. 4, 2025).
How to tell if you have this one
Check for WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems with catalog numbers WCR1523 or WCR2523. All lots of this product are affected.
Brand
Biosense Webster
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if your device has catalog numbers WCR1523 or WCR2523 for the WaveCrest LAA 32mm occlusion system.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall indicates a risk during recapture attempts, but the device is not unsafe for normal use. Medical professionals should follow the recall instructions.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2878-2018 (May 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2878-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.