Tiger Paw System II Recalled Due to Risk of Heart Tissue Tears and Serious Bleeding
The Tiger Paw System II is a medical device used during open-heart surgery that is manufactured by Maquet Medical Systems. The device is used to obstruct the left atrial appendage during the procedure. But numerous reports of the Tiger Paw System II causing patients serious injury have surfaced recently, and the device is being recalled and added to the U.S. Food and Drug Administration’s (FDA) list of defective medical products.
The Tiger Paw System II can tear the atrial appendage during open-heart surgery, which can lead serious bleeding. According to an FDA press release, these bleeding events have resulted in 51 reports of adverse health events and one fatality.
Facilities that use the Tiger Paw System II have been instructed to examine their inventory of devices to see if any are included in the recall. Any affected products should be removed from inventory, quarantined, and sent back to the manufacturer along with a completed recall form.
Anyone who has been harmed by the device during a surgical procedure should contact their surgeon and FDA officials to report the issue.
At Ferrer, Poirot & Wansbrough, our personal injury lawyers are here to help protect the rights of defective medical device injury victims. If you believe you were injured by the Tiger Paw System II, contact us today.