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surgical staple recall, Chicago Illinois product liability lawyerWhen the Federal Drug Administration (FDA) issues a recall, it is classified into one of three classes: Class I, II, or III. A Class I recall is the most serious recall the FDA issues. The TigerPaw II system recall has been classified as a Class I recall and patients who have had the system used during heart surgery should immediately speak with their surgeon. Patients who have had the staples used during surgery may also want to consider contacting a product liability attorney to talk about compensation from Maquet Medical Systems, the maker of the TigerPaw II system, for a product liability case.

The TigerPaw II system is a surgical staple used to close tissue in the left atrial appendage of the heart. It has been reported to cause tearing and bleeding in the heart tissue due to not closing completely. The FDA recall affects all TigerPaw II systems, which is over 4,000 TigerPaw II systems. They recommend the staples be immediately removed, quarantined, and replaced.

When the FDA classifies a recall as a Class I it is because there is a  strong likelihood that the product will cause serious adverse health consequences or death if use of the product continues. Maquet Medical Systems received 51 reports of adverse side effects and one death associated with the TigerPaw II system between April 2013 and March 2015.

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