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FDA Recalls Tiger Paw System II Surgical Staples

By Burg Simpson

May 7, 2015   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

On May 7, 2015, the Food and Drug Administration (“FDA”) announced an urgent “Class I” recall[1] of all Tiger Paw System II surgical staples. The Tiger Paw surgical staples are manufactured by Laax, Inc. and are used to close tissue in the left atrial appendage of the heart. According to the FDA, incomplete closure of the surgical staples “may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall (top left chamber) during the use of the device.”  To date, Maquet Medical Systems (the company handling the recall), has reported 51 reports of adverse events and one death. The devices at issue were distributed between April 1, 2013 and March 23, 2015. FDA Safety Alert

If you or a loved one suffered injuries that you believe were caused by the use of Tiger Paw surgical staples, contact one of the experienced attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

 

[1] “Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

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