Thomas Medical Products Issues Class I Recall - A defect in the company's Transseptal Sheath Introducer Kit may lead to serious complications - ModernMedicine

Thomas Medical Products Issues Class I Recall - A defect in the company's Transseptal Sheath Introducer Kit may lead to serious complications - ModernMedicine: "On March 5, the U.S. Food and Drug Administration and Thomas Medical Products Inc. (TMP) announced a Class I recall of the Transseptal Sheath Introducer Kit (other trade names include HeartSpan, CHANNEL FX, Torflex, and Braided Guiding Introducer Kit), as the sheath tip may break off and separate during heart procedures and lead to a blockage that may cause permanent injury such as a stroke, heart attack or death." [Modern Medicine]