# FDA recall Z-2878-2018

> **Biosense Webster, Inc.** · Class I · device recall initiated 2018-05-07.

## 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

- **Recall number:** Z-2878-2018
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2878-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2878-2018. Source: US FDA. Licensed CC0.

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