Home / Recalls / Laax, Inc. / Z-1462-2015

Z-1462-2015 Class I Terminated

Recalled by Laax, Inc. — Livermore, CA

Recall Details

Product Type: Devices
Report Date: April 29, 2015
Initiation Date: March 25, 2015
Termination Date: March 17, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: ~4,154 units distributed in US - both part numbers

Product Description

TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.

Code Information

Part number C-TP-1509 (9 connector) All serial numbers/lots