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FDA Issues Recall Notice about TorFlex Transseptal Guiding Sheath Kit

FDA Issues Recall Notice about TorFlex Transseptal Guiding Sheath Kit

The FDA recently warned of a recall affecting TorFlex Transseptal Guiding Sheath Kit manufactured between December 2011 and July 2013. The maker of this defective medical device, Baylis Medical Company Inc., recalled the device and issued an Urgent Device Recall letter to its customers.

The recalled device was designed "for safe and easy catheterization and angiography [a type of X-ray imaging] of specific heart chambers and locations." However, one of the device's components present in the defectively manufactured kits could cause the removal of small particles. This particulate matter could then "potentially migrate into a patient's bloodstream." Due to the risk of serious health consequences, the device recall was "Class I" - the most serious type of recall.

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373958.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm373911.htm

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