The U.S. Food and Drug Administration announced Friday that Medtronic is recalling certain models of its Angiographic Guidewire Component due to sterilization issues.

Medtronic’s recall includes five models distributed between Nov. 23, 2007, and March 29, 2021, the FDA said in a statement. The Class 1 recall is the most serious designation and indicates the use of these devices may cause serious injury or death.

“Medtronic Vascular is recalling the Angiographic Guidewire Component because devices were not sterilized before being shipped directly to hospitals,” the FDA said July 2. “If patients are exposed to the non-sterile device, serious adverse events could occur such as infection, sepsis, and death.”

Guidewires are used during angiography or other interventional procedures to help clinicians place cardiac catheters. The recall applies to more than 54,000 components in the U.S.

“There have been two complaints, and no reported injuries or deaths related to this issue,” the statement read. “However, there is potential for underreporting as physicians may not have been aware that devices were non-sterile.

Medtronic sent an urgent recall letter to its affected customers on May 4 urging providers to identify and quarantine all unused, affected guidewires. An amended letter sent out on June 3 advised customers to report adverse events or quality problems to FDA and Medtronic.

Read the full statement here.