Laax, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1461-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class I

Date Initiated: March 25, 2015

Date Posted: April 29, 2015

Recall Number: Z-1461-2015

Event ID: 70853

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.

Status: Terminated

Product Quantity: ~ 4,154 total units in US - both model numbers

Code Information:

Part number C-TP-1507 (7 connector) All serial numbers/lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated