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FDA Recalls TigerPaw II Surgical Staple Systems

Posted on in Product Liability

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.

Patients who have already undergone heart surgery and recovery will now have to go through another surgery and recovery period to have the recalled product removed and replaced. This will not only cost the patient more time, but also more stress and worry. If they are unable to have the TigerPaw II system replaced and removed in an acceptable timeframe, the atrial wall in their heart can continue to bleed and cause more problems. No patient should have to worry about whether or not a surgical staple will cause more problems or having to go through a repeat surgery and recovery. Patients should speak with a product liability lawyer to discuss and understand their rights for compensation from having to have a recalled product removed and replaced.

Surgery and recovery is stressful enough by itself that patients should not have to be concerned about having a product used during your surgery being recalled due to tearing or bleeding. Contact a Chicago product liability attornrey today. Hurley McKenna & Mertz, P.C. works hard to fight for their clients’ rights to compensation in product liability cases. They know how important it is for their clients to be able to take care of themselves and their families and the anxiety a medical product recall can have on them. Call the law office of Hurley McKenna & Mertz, P.C., at 312-553-4900 to schedule a complimentary case consultation.
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