On the heels of a string of recalls that culminated in the total discontinuation of its HeartWare blood pump, Medtronic has issued yet another medical device recall.
This time, the medtech giant is calling for the return or exchange of tens of thousands of angiographic guidewire components, used to lead catheters through blood vessels during certain minimally invasive cardiovascular procedures.
According to an FDA notice—which categorizes the recall as Class I, its most serious type—several models of the guidewire were not sterilized before being shipped to hospitals. The use of non-sterile devices could potentially result in sepsis, other infections or death, the agency said.
So far, only two complaints pertaining to the guidewire have been filed with the FDA, with no reports of related injuries or deaths. However, the agency noted, some serious adverse events caused by the guidewires may have gone unreported since physicians did not know the devices had not been sterilized.
The recall covers nearly 55,000 guidewires distributed over the course of more than 13 years, between November 2007 and March 2021.
Medtronic initially alerted customers of the recall in early May. At the time, the company asked facilities to identify and either return or exchange all of their unused components that matched the affected model numbers.It also noted that patients who underwent procedures using the devices should be monitored under each facility’s standard care protocols.
An amended urgent recall letter sent to healthcare providers a month later, on June 3, tasked facilities with notifying all patients who were treated with the non-sterilized guidewires. It also asked them to report all adverse effects of the devices to Medtronic and the FDA.
This wide-ranging recall follows Medtronic's trio of Class I recalls related to its long-troubled HeartWare Ventricular Assist Device, spanning November 2020 and May of this year, with the company announcing in early June that it was discontinuing the device altogether.
Though Medtronic will no longer manufacture or distribute the implanted heart pump and asked hospitals to cancel all future implants, it advised against removing any existing implants.
Instead, the approximately 4,000 people currently using the HeartWare device should continue to use it as directed. Medtronic will continue to provide necessary replacements of the device’s components and pledged to launch a support program for affected patients and their care teams.