Transseptal Sheath Introducer Kit Recall: Risk Tip May Break Off

A Class 1 medical device recall has been issued for Transseptal Sheath Introducer Kits by Thomas Medical Products, a subsidiary of General Electric’s healthcare division, because the sheath tips can break off during heart procedures, potentially causing permanent injury or death. 

The sheath introducer recall was announced by FDA on March 5, after Thomas Medical Products notified healthcare professionals last month about potential problems after receiving at least five adverse event reports. The FDA recall notice says that the sheath introducer kits have tips that can separate and potentially cause damage to the heart or move through arteries into the brain or other vital organs and cause blockages, damage and death.

The Transseptal sheath introducers are used to pass heart catheters through the middle heart wall from one side of the heart to another.

The sheath introducer recall affects 119 lots of Transseptal Sheath Introducer Kits distributed worldwide between October 1, 2006 and December 27, 2009. The kits were sold under brand names including HeartSpan, CHANNEL FX, Torflex, and the Braided Guiding Introducer kit. For a full list of lot numbers affected by the recall, see the Thomas Medical Products press release.

Class 1 recalls are the most serious classification of medical device recall, and are issued when the FDA believes that a problem could reasonably result in serious injury or death.

The Transseptal Sheath Introducer Kit recall is the fourth sheath pulled by Thomas in recent months. The company issued a Safesheath introducer recall in February, a Viper Sheath introducer recall in November, and a Cordis Crossover Catheter Sheath recall in October. All of the recalls involved manufacturing defects that could lead to pieces of the sheaths breaking off inside the body.

Customers who have recalled sheaths may contact the company at 1(866)466-3003. Anyone who ha suffered an adverse event due to defective Thomas Medical Product sheaths can contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.