Medtronic Vascular has issued a recall for certain models of its Angiographic Guidewire Component, used during angiography and interventional procedures, because the devices weren’t sterilized before being shipped to hospitals.
The US Food and Drug Administration (FDA) announced today that it has classified the recall as Class I, and cautioned that “if patients are exposed to the non-sterile device, serious adverse advents could occur such as infection, sepsis, and death.”
There have been two complaints, and no reported injuries or deaths related to this issue, the agency said, “however, there is potential for underreporting as physicians may not have been aware that devices were non-sterile.”
A total of 54,997 devices, distributed between November 23, 2007, and March 29, 2021, are affected by the recall. Specific model numbers can be found here.
Medtronic Vascular initiated the recall on May 4, 2021, and asked customers in an Urgent Medical Device Recall letter to return or exchange all unused affected components. The letter was amended on June 3, further instructing customers to report adverse reactions or quality problems with the component to the FDA and Medtronic.
Reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program, or by calling the FDA at 800-FDA-1088, or by calling Medtronic at 800-551-5544, the letter adds.