(Reuters) - U.S. 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.
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.
Shares of the company closed at $6.74 on Tuesday on the New York Stock Exchange.
(Reporting by Kavyanjali Kaushik in Bangalore; Editing by Maju Samuel)
(This June 14th story is corrected to remove paragraph 3 as it inadvertently referred Atlantis SR Pro2 cathether as a replacement for iCross)