The FDA has issued on update on Medtronic’s Feb. 4 recall of its TurboHawk Plus directional atherectomy system, deeming it a Class 1 recall because of the risk of serious injury or death if the catheter’s tip should break off during use.

The devices were manufactured between July 21 and Nov. 25, 2021, and distributed from Sept. 27, 2021, to Jan. 25 of this year. There are 686 affected products that were distributed in the U.S.

The fault carries a danger of serious adverse events, such as arterial rupture, ischemia and blood vessel complications that could require surgical repair. There have been no complaints of actual tip damage and no reported injuries or deaths so far, the FDA said.