Safesheath CSG Sheath Introducer Recall: Risk of Fracture

A Class 1 medical device recall has been issued for Safesheath CSG Sheath Introducer Systems by Thomas Medical Products, Inc. due to reports that the tip of the sheath can break off and enter patients’ blood vessels.

The Safesheath introducer recall was posted this week by FDA after the manufacturer sent letters to health care professionals and customers in December. It is the latest in a series of recalls of sheaths and catheter products made by Thomas Medical Products due to manufacturing problems. The recall is classified as a Class I, the most serious, because the Safesheath defect has the risk of causing serious injury or death.

Thomas Medical Products is a subsidiary of General Electric’s healthcare division.

The Safesheath CSG sheath introducer systems, distributed by Pressure Products, Inc., are tube-like devices that are placed into blood vessels. The Safesheath has an infusion side port that allows doctors to place defibrillator wires and catheters easily into blood vessels once the sheath is in place. The recall has been issued because the tips of the sheaths can break off and potentially move through the blood vessel to the brain or heart, which can cause serious injury or death.

Thomas Medical Products has received 38 reports of tips coming separated, but did not indicate whether any of the cases resulted in serious injury or death.

The recall affects certain lots of Safesheath CSG Sheath Introducer systems distributed from December 1, 2005 through December 14, 2009. A complete listing of affected lots and catalog numbers is available in a press release put out by GE on January 29.

The Safesheath recall is the third sheath pulled by Thomas in the recent months. The company issued a recall for the ViperSheath Sheath Introducer in November, and a Cordis Crossover Catheter Sheath recall was issued in October. In both cases the sheaths were found to stretch and fracture, potentially causing injury or death to patients. In both cases, there were reports of patients who required surgery to remove pieces of the sheaths after they broke inside their bodies.

Thomas Medical Products and Pressure Products are notifying customers of the recall and arranging for the return of unused products. 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.