TigerPaw Surgical Staple Recall Issued Over Risk of Tears, Bleeding in Heart

Following at least one patient’s death and dozens of reported problems, federal health regulators warn that the TigerPaw surgical staple system may place patients at risk of serious injury or death. 

A TigerPaw System II recall was posted by the FDA on May 7, after the manufacturer received at least 51 reports of the device failing to completely close the incisions in the left atrial appendage, resulting in heart tissue tears, bleeding and damage to the left atrial wall.

The FDA is aware of at least one fatality that is believed to have been caused by the device failing to close the surgical staples. The agency indicates that the action is categorized as a class I recall, the most serious recall classification.

The TigerPaw System II is a mechanical medical device that consists of a delivery tool and implantable fastener to occlude the left atrial appendage and conform to the surrounding anatomy and tissue thickness when placed on the ostium of the appendage. The surgical staple system is designed to completely close the incisions of the tissue and intended to reduce the risk of postoperative stroke caused by atrial fibrillation.

Prior to the recall, the FDA approved the use of the TigerPaw System II for left atrial appendage occlusion in cardiac surgical procedures under certain circumstances when the surgeon has an unobstructed view of the heart without the assistance of cameras.

The recall impacts 4,154 TigerPaw System II devices manufactured in early 2013 by LAAx Inc., of Livermore, California. Maquet Medical Systems subsequently purchased LAAx Inc., along with the TigerPaw System in which they distributed the devices to hospitals and medical facilities across the U.S. between April 1, 2013 and March 23, 2015.

Maquet Medical Systems sent an “Urgent Medical Device Recall Notice Immediate Action Required” letter dated March 30, 2015 to all affected customers with notice of the potential hazards and instructions to immediately examine existing inventory, remove and quarantine any TigerPaw II devices and to complete and return the Medical Device Recall Form included in the notice.

The FDA only issues Class I recalls for the most serious situations where there is a reasonable probability that the use of or exposure to a dangerous product will cause serious adverse health consequences including death.

Healthcare physicians with the recalled TigerPaw II systems in their inventory should immediately discontinue use of the product and health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by either calling at 1-800-332-1088 or visiting them online at www.fda.gov/MedWatch/report.