FDAMarch 25, 2015device
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
What to do
FDA enforcement status: Terminated
Brands named
laax
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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