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FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

The FDA recently warned healthcare professionals of a recall of TigerPaw System II by Maquet Medical Systems. The TigerPaw System II "is a surgical staple used to close tissue in the left atrial appendage," a muscular ear-shaped pouch in the heart. Maquet Medical Systems has recalled all lots of these medical devices that were distributed between April 2013 and March 2015. The reason for the nationwide recall is an "incomplete closure" of the TigerPaw System II which may result in heart tissue tears and bleeding. Maquet Medical Systems has received dozens of reports of adverse events, including one death.

On behalf of the manufacturer Laax, Inc., Maquet Medical Systems has sent an Urgent Medical Device Recall letter with safety instructions to its customers. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty devices] will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446116.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm446087.htm

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