Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1462-2015 — 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).

U.S. FDA — Device Enforcement · United States · 2015-03-25 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1462-2015
Date of alert
2015-03-25
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Laax, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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