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U.S. Department of Health and Human Services


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Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall

Audience: Cardiologists, Hospital Risk Managers

[Posted 03/05/2010] FDA and Thomas Medical Products notified healthcare professionals of a Class I recall of the Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit), which are prescription medical devices used to 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. These devices were manufactured and distributed from October 1, 2006 through December 27, 2009.

[03/05/2010 - Recall Notice - FDA]