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Recall Observatory FDA recall evidence

Device product

WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.

Z-2878-2018

May 07, 2018

Class I

Product summary

Firm
Biosense Webster, Inc.
Event
Event 80720
Status
Terminated
Classification
Class I
Quantity
25 units
Official record key
device-enforcement:Z-2878-2018

Official wording

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.

Code information: All lots.

Distribution pattern: No U.S. Distribution. International Distribution only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.