Biosense Webster, Inc. Recall: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32
Biosense Webster, Inc. Recall: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Biosense Webster, Inc.; Product: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.; Reason for
| Recalling firm | Biosense Webster, Inc. |
|---|---|
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | No U.S. Distribution. International Distribution only. |
| Recall initiated | 20180507 |
| Recall number | Z-2878-2018 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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