WaveCrest Left Atrial Appendage recall
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Why was WaveCrest Left Atrial Appendage recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots.
- Product
- WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 25 units
- Distribution
- No U.S. Distribution. International Distribution only.
- Recall date
- September 5, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)