Tigerpaw System II – Class 1 Recall
The TigerPaw System II is a surgical staple, manufactured by LAAx of Livermore, CA, which is used to occlude, or close, surgical openings in the Left Atrial Appendage (LAA) of the heart. Based on 51 adverse events and one death, the U.S. Food and Drug Administration (FDA) has issued their most urgent recall for this product as of May 7, 2015.
The TigerPaw System II is a mechanical device that is made up of a single use delivery tool and implantable fastener to occlude the LAA. The silicone fastener is designed to conform to the LAA anatomy and tissue thickness when it is placed on the ostium of the appendage. Occlusion of the LAA is intended to reduce the risk of postoperative stroke caused by atrial fibrillation.
The Class 1 recall requires the manufacturer to obtain outstanding stocks of the product and to remove and quarantine them from the market. This type of recall, per the FDA, is reserved for those instances where there is a “reasonable probability that the use of these products will cause serious adverse health consequences or death.”
LAAx of Livermore, was acquired by Maquet Medical Systems of Rastatt, Germany, in May 2013. The TigerPaw System II has been distributed from April 1, 2013 through March 23, 2015. 4,154 units have been distributed to 223 customers. Maquet issued a statement via email, which reads, in part: “These products were distributed only to hospitals and the recall is virtually complete.”
Tigerpaw System II Lawsuits
If you or a family member, were treated with a TigerPaw System II and had complications which resulted in injury or death, please contact the Richard Harris Law Firm for a consultation. To discuss your situation with our office, please call (702) 444-4444.
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Tigerpaw System II