The Fridley, Minn.-based company said the devices were recalled because of a risk of the outer material of the catheter separating from the device, resulting in detached fragments that could expose the underlying stainless steel braid wires. The fragments could remain in a patient’s bloodstream, which, along with attempts to retrieve the fragments, could result in blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death.
Medtronic said it received five customer complaints regarding the device, but no serious injuries or deaths were reported. The company said the recall will not affect the Medtronic Launcher coronary guide catheter or any other Medtronic coronary stents, balloons or implantable devices.
The FDA identified the recall as a Class I recall, denoting the risk of serious injuries or death. Medtronic said that it recalled 106,298 devices in the U.S. that were manufactured between March 10, 2017, and March 14, 2019, and distributed between April 3, 2017, and April 4, 2019. Medtronic initiated the recall on March 15.
The 6 French Sherpa NX active guide catheter is designed to access veins and arteries both inside and outside the heart, potentially to pair with guidewires and other interventional devices for administering drugs or fluids into blood vessels.
Shares of MDT were down -1.6% at $105.57 per share in mid-afternoon trading today.