The FDA has announced that Medtronic Vascular is recalling nearly 55,000 angiographic guidewire components because they were not properly sterilized before being shipped to hospitals. This is a Class I recall, which means the issue could lead to serious injury or death.
All components included in this announcement were distributed from November 2007 to March 2021.
Customers have been instructed not to use any of the affected devices; they should be identified and quarantined immediately. They can then be returned or exchanged to Medtronic.
“If patients are exposed to the non-sterile device, serious adverse events could occur such as infection, sepsis, and death,” according to the FDA’s announcement.
Any adverse reactions or quality issues related to these devices should be reported to both the FDA and Medtronic. Thus far, there have been two official complaints, but no reported injuries or deaths.
The full FDA alert is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.