WaveCrest Left Atrial Appendage — Class I medical device recall Z-2878-2018
Terminated recall by Biosense Webster, Inc., reported 2018-09-05. When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in
| Recall number | Z-2878-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-11-14 |
| Quantity | 25 units |
| Model numbers | WCR1523, WCR2523 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2878-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.