FDA Device recall Z-2878-2018
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523
- FDA Device
- Class I
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class I recall of WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523 by Biosense Webster, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2878-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-07 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biosense Webster |
| Distribution | n/a |
Product
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Reason
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.
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Biosense Webster
- VARIPULSE Bi-Directional Ablation Catheter REF D141201
FDA Device · Class I · 2025-03-12 · Biosense Webster - CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
FDA Device · Class II · 2024-03-20 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
FDA Device · Class II · 2023-04-12 · Biosense Webster - CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501
FDA Device · Class II · 2022-09-14 · Biosense Webster
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2878-2018%22
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