Thomas Medical Announces Recall of Safesheath Product

Sheath tip can break off in blood vessels, potentially causing blockages

FRIDAY, Feb. 5 (HealthDay News) -- The U.S. Food and Drug Administration and Thomas Medical Products Inc. have notified health care professionals of a recall of certain lots of the Safesheath Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport.

The product is a tube-like device placed into blood vessels to insert pacing or defibrillator wires or catheters. According to the notification by the FDA and the product's manufacturer, Thomas Medical, the recall was issued because the product's sheath tip could break off and separate while inside a blood vessel.

If the sheath tip breaks off, it could move into organs such as the lungs or heart or into the arteries, possibly causing a blockage and leading to permanent injury such as stroke or myocardial infarction, or even death. Thomas Medical has received 38 adverse event reports of the sheath tip becoming separated.

"Thomas Medical Products and PPI [Pressure Products Inc., the distributor] are notifying all customers about this recall through notices sent to each customer. Thomas Medical Products and PPI are also arranging for return of all unused products," according to a Jan. 29 press release issued by the manufacturer.

Recall Notification
Press Release

Physician's Briefing