Medtronic Vascular Recalls Angiographic Guidewire Components

Medtronic Vascular has issued a voluntary recall for certain angiographic guidewire components that were shipped out to hospitals before they were sterilized. The US Food and Drug Administration has categorized this as a Class I recall, the most serious type.

“There have been two complaints, and no reported injuries or deaths related to this issue,” the agency said in its recall notice posted Friday. “However, there is potential for underreporting as physicians may not have been aware that devices were nonsterile.” Exposure to nonsterile devices could result serious adverse events including infection, sepsis, and death.

Hospitals with affected components—a total of 54,997 distributed between November 23, 2007, and March 29, 2021—should return or exchange them.

The recall was initiated by Medtronic Vascular on May 4, when the company sent out an Urgent Medical Device Recall letter to customers. The letter was amended on June 3 to ask customers to report adverse reactions or quality problems tied to use of the components to the FDA and Medtronic and to “utilize standard hospital practice and policies to notify patients who were treated with the recalled components.”

The issue affects components with model numbers 107042, 107044, 107447, 110003, 110004.