Medical device manufacturer Boston Scientific has recalled Chariot Guiding Sheath devices over the risk of shaft separation.
The FDA class-1 recall was initiated by the company after receiving fourteen complaints for shaft separation, of which four involved separation of the distal shaft.
According to the company, the shaft separation occurred during device preparation or use.
The most severe outcome of the failure is embolism of device fragments, which may lead to obstruction of blood flow or additional intervention to remove a device fragment.
Obstruction of blood flow is expected to result in injuries such as stroke, kidney damage or damage to the intestines or limbs.
The firm has requested all affected healthcare facilities to immediately discontinue the use of Chariot Guiding Sheaths and return unused devices.
The company also noted that no permanent injuries or patient deaths were reported, to date.
In 2011, the company recalled iCross coronary imaging catheters used in intravascular ultrasound (IVUS) imaging in patients who are candidates for transluminal coronary interventional procedures in the US, Puerto Rico, Trinidad, Tobago and the American Virgin Islands.
The catheters are developed for use with the firm’s ClearView Ultra, Galaxy, Galaxy2 or iLab IVUS imaging consoles.