The FDA Recall of the TigerPaw System II by Maquet Medical Systems
The FDA issued a Class I recall of the TigerPaw System II on May 7, 2015. The TigerPaw System II is a surgical staple manufactured by Maquet Cardiovascular LLC. The recall is in response to reports that the TigerPaw II has caused heart tissue tears and internal bleeding.
What are the Details of the FDA Recall?
The TigerPaw II is a medical device used for some cardiac surgeries. The Tiger Paw surgical staples are specifically employed for left atrial appendage (LAA) occlusion. It is believed that the TigerPaw System II device may not completely close when it is implanted in the LAA. This incomplete closure can result in tissue tears of the left atrial wall (the top left chamber of the heart). Maquet has received 51 reports of adverse events and one report of a death associated with the use of the TigerPaw II. The TigerPaw II models that are under a recall were distributed from April 1, 2013 through March 32, 2015. All customers (typically medical service providers) are instructed to examine their inventory for the Tiger Paw System II models and remove, quarantine and secure any recalled devices.
Do I Have a Kentucky Tiger Paw System II Lawsuit?
The FDA recall is a Class 1 recall which means it is a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. If you or a family member in Kentucky have suffered serious health problems from the Tiger Paw System II surgical staple, please contact a lawyer. Brett Oppenheimer is a Kentucky injury attorney who can help to guide you through the legal process associated with product liability and medical device litigation. Brett can help you determine if you may be entitled to financial compensation from Maquet Medical Systems for your suffering. Call (502) 242-8877 for a free consultation about your experience with the Maquet TigerPaw II.