Boston Scientific announced on Dec. 9 that it had voluntarily recalled its Chariot guiding sheath after receiving 14 complaints of shaft separation. The FDA classified it as a Class 1 recall, which is the most serious type of recall.
The Chariot guiding sheath is used to introduce interventional devices during peripheral vascular procedures. Of the 14 complaints, four involved shaft separation during device preparation or use.
If the shaft separates, it could lead to embolism of the device fragments and obstruction of blood flow or additional intervention to remove a device fragment. If the blood flow is obstructed, patients may have severe injuries such as stroke, kidney damage or damage to the intestine or limbs. No permanent injuries or deaths have been reported, according to Boston Scientific.
The company said in a news release that healthcare facilities should immediately discontinue use of affected devices and physicians should contact patients who have undergone procedures with the Chariot guiding sheath to confirm their status.
On Nov. 27, the FDA announced Boston Scientific had recalled its RotaWire Elite Guidewires and wireClip Torquer Guidewires after receiving three reports of the wires cracking and separating from the Rotablator Rotational Atherectomy System.