The U.S. Food and Drug Administration (FDA) has announced a Class I recall of all lots of Macquet Medical Systems’ TigerPaw System II. The TigerPaw System II is an implantable device used to close ruptured tissue in the left atrial appendage of the heart. However, according to the FDA, if not completely closed, the TigerPaw System II may result in tissue tears or bleeding during use of the device.
Class I recalls are the most serious class of recalls, and are issued when recalled products have a reasonable probability of causing serious injury or death. Macquet Medical Systems has received 51 reports of device malfunction from a TigerPaw System II, one of which involved death. According to the FDA website, Maquet Medical Systems sent out an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter on March 30, 2015, to customers who may have been affected by the TigerPaw System II. The letter provides a description of the product, problem, and actions to be taken, and instructs consumers to: immediately locate any recalled TigerPaw System II devices in inventory; remove and isolate them in a secure location; and complete and return a response form.
Injuries, deaths, and property damage resulting from consumer products cost the nation over $1 trillion each year in medical, repair, and other expenses. The attorneys at Lopez McHugh are dedicated to protecting the rights and welfare of consumers who have suffered from defective products. If you or someone close to you was injured by a faulty TigerPaw System II, contact our lawyers today for a free consultation.