FDAFDA · Food and drugs·Recall number Z-2878-2018
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Published September 5, 2018 · Recall initiated: May 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- No U.S. Distribution. International Distribution only.
- Lot
- All lots.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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