Medtronic has logged another Class I medical device recall - the FDA’s most serious type of recall - after reports of its HawkOne system causing various injuries.
This recall covers over 95,000 devices that have been distributed in the United States since 2018.
The HawkOne system is a catheter and powered cutter that is designed to erase plaque build-up inside peripheral arteries by spinning at up to 12,000 RPM. The main issue with the product is that the HawkOne’s guidewire can become bent and stick out while it is being used.
Consequently, this results in the catheter tip separating or breaking off, which can lead to severe complications such as a ruptured or blocked blood level. In this case, surgery would be required to repair the artery and retrieve the device. The FDA release states the following has happened or could happen:
“lead to serious adverse events including a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), and/or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip.”
According to the FDA’s recall notice, there have been 163 recorded complaints about the device, linked to 55 injuries and 0 deaths.
In the December 2021 letter that Medtronic sent to healthcare providers, they stated that no action is required for patients who underwent procedures without any incidents and that current patients should be monitored per the practice’s normal follow-up procedures. In addition, Medtronic reiterated the existing warnings in the HawkOne’s instructions regarding the possible risk of prolapsed guidewires.
Before its newest recall, Medtronic also encountered issues with two of their devices last year - the HVAD implant kit, and the HeartWare blood pump. Both of these products have since been discontinued, in addition to tens of thousands of angiography guidewires that were not properly sterilized before being shipped.
If you or a loved one has been impacted by the HawkOne system, please contact the New York attorneys at Rheingold, Giuffra, Ruffo, & Plotkin for a free consultation today. Our experienced team has over 50 years of experience with product liability and medical malpractice cases. We have successfully worked on various Medtronic cases before, including their implantable defibrillator and their balloon catheter.