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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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superbug product liability, Chicago personal injury lawyerIn the last several months, two hospitals in California have reported outbreaks of what officials are referring to as the CRE superbug. At Ronald Reagan UCLA Medical Center in Los Angeles, two patients died after being infected and five others continue to receive treatment. Medical officials have reached out to nearly 180 additional patients who may have been exposed at the facility. The outbreak has been traced to a particular medical device, which federal regulators are, so far, reluctant to pull from the market.

Carbapanem-resistant enterobacteriaceae, or CRE, is a bacterial pathogen which can cause infections resistant to most antibiotic treatment. Certain bacteria, such as E. coli,  which are common to the human digestive system, can evolve and become carbapanem-resistant, resulting in strains of CRE potentially producing infections that are very difficult to treat. The Centers for Disease Control and Prevention (CDC) acknowledges the dangers inherent to CRE infections and has reported that the superbug may be fatal in up to 50 percent of infected patients.

Each of the infected UCLA patients had undergone a relatively minor endoscopic procedure utilizing a device known as a duodenoscope. More than half a million patients each year have similar procedures done with the device, which is an imaging tool used to detect and diagnose issues in the upper small intestines, gall bladder, and pancreas. A particular duodensoscope at UCLA, however, was found to be the source of the CRE exposure, according hospital officials. A subsequent CRE outbreak at Cedars-Sinai Medical Center, also in Los Angeles, is currently being investigated to confirm that a similar device was to blame.

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