The FDA, in conjunction with GE Healthcare's subsidiary Thomas Medical Products, has issued a Class I recall of the SafeSheath CSG Coronary Sinus Guide Hemostatic Introducer System, placed into blood vessels to insert pacing or defibrillator wires with infusion sideport, due to the potential of the sheath tip to fragment and embolize inside the blood vessel during use, causing serious cardiac events.
According to Malvern, Pa.-based Thomas Medical, sheaths manufactured from Dec. 1, 2005, to Dec. 1, 2009, with various lot numbers (found here) are included in the recall.
According to the FDA, if the sheath tip breaks apart during a procedure, it could move through the blood vessels and into the lungs, heart or arteries to embolize, creating blockages that can lead to cardiac events including stroke, heart attack or death.
On Dec. 23, the company issued an e-mail message to its distributer, Pressure Products, asking them to cease distribution of sheaths and return the unused devices affected by the recall.
The company has already received 38 adverse event reports in regards to the CSG introducer tip becoming separated.
Although voluntarily recalled, the FDA suggests that all adverse events be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.