WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Reported: September 5, 2018 Initiated: May 7, 2018 #Z-2878-2018
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.
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 25 units
- Distribution
- No U.S. Distribution. International Distribution only.
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.. Recalled by Biosense Webster, Inc.. Units affected: 25 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Critical. Recall number: Z-2878-2018.
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