Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
TIGERPAW System II Recalled by Laax, Inc. Due to Increase of field reports involving issues with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Laax, Inc. directly.
Affected Products
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).
Quantity: ~4,154 units distributed in US - both part numbers
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Laax, Inc.
Laax, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report