Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
MedSun: Newsletter #47, April 2010

FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of Torflex Transseptal Guiding Sheath, a medical device used to pass heart catheters from the right to the left side of the heart. The sheath tip may break off and separate during heart procedures. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart.

Additional Information:

FDA MedWatch Safety Alert. Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall. March 11, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204177.htm


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