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U.S. Department of Health and Human Services


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Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall

Audience: Cardiology, Hospital Risk Managers

[Posted 03/11/2010] 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. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death. This product was manufactured from April 11, 2007 through March 3, 2008 and distributed from April 2007 through May 2009. Recalled model and lot numbers are noted in the Recall Notice.

[03/11/2010 - Recall Notice - FDA]