Boston Scientific Corp. (NYSE:BSX) announced a voluntary Class 1 recall of all unused units of its iCross coronary imaging catheters late last month, citing problems with tip detachments.

The U.S. Food & Drug Administration has expanded the recall to include BSX’s Atlantis SR Pro2, which the med tech giant had named as a replacement for the iCross catheters.

The FDA classified the recall as Class I because it believes the products could cause serious injury or death. The recall affects more than 110,000 devices distributed in the U.S. and overseas.

The catheter tips can break off inside a patient causing tissue damage or heart attack, the FDA recall states.

Between April 1 and May 10 this year Boston Scientific confirmed eight occurrences of catheter tip detachments due to embrittlement.