BANGALORE Health regulators have expanded the recall of Boston Scientific Corp's coronary imaging catheters by including a new model.
The Food and Drug Administration said on its website the recall involves 110,020 iCross and Atlantis SR Pro2 devices distributed within and outside the United States.
Atlantis SR Pro2, included in the recall, was earlier named by the company as a replacement for 29,664 iCross catheters, which were pulled off the shelves earlier in the year.
These catheters are used for ultrasound examinations of blood vessels in patients who are candidates for interventional procedures.
In May, Boston Scientific recalled iCross catheters after receiving reports of the catheter tip detaching during procedures. The medical device maker had indicated that it had identified a solution to the problem.
On Tuesday, the FDA said the catheter tip can break inside the patient causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.