Device recalled for link to deaths, injuries highlights bigger vascular care trend

A medical device is raising concerns following its FDA Class I recall (the most serious kind) for potential links to injuries and deaths.

The device? Becton, Dickinson and Company’s (BD) Rotarex Atherectomy System, designed to treat peripheral artery disease (PAD) by using a spinning helix to clear out plaque in arm and leg arteries in a procedure called an atherectomy.

The FDA noted on March 20 that BD has reported at least four deaths, 30 serious injuries, and 115 complications associated with its device, linked to a helix that broke or cracked during use.

Recalls don’t always mean market removal, and the device is still for sale with updated use instructions, a practice that has sometimes attracted criticism in the past.

But even though this device is in the spotlight, the recall reflects a potentially larger problem with atherectomies, which have gone from making up 8.5% of peripheral vascular interventions in 2019 to 19.7% in 2020, according to a 2022 study in the Journal of Vascular Surgery.

“It’s just another example of how atherectomy use in the treatment of PAD is running rampant,” Caitlin Hicks, a vascular surgeon and vice chair of research for the Department of Surgery at the Johns Hopkins University School of Medicine, told Healthcare Brew. “This specific [device] problem is coming to light because of the [larger] system problem and the overuse that results from it.”

Failures in the field? BD isn’t alone in reporting malfunctions. According to FDA data, the most common cause of adverse events for this type of system over the last five years has been a break (1,338 events) or detachment of part of the device (878 events). There were 5,000+ adverse events reported between 2020 and April of this year.

Hicks said some potential injuries can happen when this procedure is used on patients who may not be ideal candidates. Hicks’ past research—plus a 2023 ProPublica investigation—helped to identify a small number of doctors potentially overusing the procedure.

“Challenges come when people start using atherectomy devices in all patients, regardless of anatomy. And we’re seeing that as an increasing trend, largely related to reimbursement policies,” Hicks said.

BD’s guidance points to this issue, too.

In a Feb. 5 voluntary medical device correction letter to customers, BD said the device can continue to be used except in certain procedural circumstances and “patient anatomical characteristics.”

Reimbursement incentives scrutinized. Hicks said one potential cause of the procedure’s overuse is Medicare physician reimbursement for outpatient atherectomy procedures is sometimes higher than alternatives like stenting and balloon angioplasty, which can accomplish similar results.

Matthew Eagleton, president of academic society the Society for Vascular Surgery (SVS), told Healthcare Brew that “there are outliers who overstep the bounds of ethics, appropriateness, and quality, perhaps driven by other motivations, including notoriety or financial gain.”

The Society for Cardiovascular Angiography and Interventions (SCAI) and the Outpatient Endovascular and Interventional Society disagree. A joint statement on SCAI’s website argues that in 2024, Medicare “actually under-reimburses atherectomy,” though “there is a further need for evidence concerning its use in patients with milder symptoms.”

What’s next? CMS and whistleblower fraud organizations have identified peripheral vascular procedures—like atherectomies—as “vulnerable to improper payments,” the US Department of Health and Human Services Office of the Inspector General said in June 2024.

The OIG is expected to finish two separate investigations into the issue in 2025 and 2026. As for Rotarex, BD spokesperson Fallon Mcloughlin told Healthcare Brew there is no need to remove it from the market. The company will “continue to monitor and investigate any issues related to this device,” Mcloughlin said.