Recall Z-2878-2018— Biosense Webster, Inc.
Class I · Terminated
Class I FDA medical device recall by Biosense Webster, Inc., initiated 2018-05-07, terminated 2020-11-14. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-05-07
- Terminated
- 2020-11-14
- Firm location
- Irwindale, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.