Vascular stents are potentially life-saving devices that hold open blocked or narrowed passages in the body. When stents are implanted in arteries, they improve blood flow.
Each year, more than 2 million vascular stents are implanted via an angioplasty procedure, and many patients have benefited from multiple stent implants.
But when defective medical devices like vascular stents are recalled, patients may find themselves subject to serious health risks. That’s why it’s important to have accurate information about the defect and about available options if an implanted stent is under recall.
What is a vascular stent recall?
According to the Food and Drug Administration (FDA) website, a recall is “when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law.” Recalls are initiated when a device is “defective, when it could be a risk to health, or when it is both defective and a risk to health.”
The FDA assigns a classification (I, II, or III) to the recall based on the risk posed to patients.
The most serious, Class I, is for a situation where there is a “reasonable chance” of a product causing serious health problems or death.
Class II recalls, meanwhile, are for situations where there is a far lesser likelihood that the product could cause a serious health problem or death.
Class III recalls, assigned to the least risky situations, are for recalls where the product is unlikely to cause a health problem or injury.
If you or a loved one has been implanted with a vascular stent that has been recalled, it’s important to understand how the recall has been classified to assess the severity of the potential health risk.
Current vascular stent recall
On the FDA website, you can access a comprehensive, searchable database of all medical device recalls. These include recalls for vascular stents.
A stent recall from August 2025 included in the database is representative of the very real risks a defective stent can pose.
The Boston Scientific Carotid WALLSTENT Monorail Endoprosthesis was recalled due to a manufacturing defect that could cause resistance when the stent delivery system is withdrawn.
The FDA identified this as a Class I recall and said the stent system’s use could cause “serious harm, such as injury to the blood vessel, damage to the stent, or release of debris that could travel to the brain and cause a stroke.”
Potential health risks of defective stents
As indicated by the recall for the Boston Scientific stent described above, defective stents can have multiple medical consequences. These include internal bleeding, blood clots, infection, heart attack, stroke, or death.
In addition to the medical consequences, patients implanted with a defective stent may experience emotional or financial hardships due to repeated or extended hospitalizations, caregiving requirements and costs, or lost income from being unable to work.
A defective stent can have a deep and widespread impact on an individual and their family.
What to do if you have a recalled stent
If you have learned that you have been the recipient of a recalled medical device—including a recalled stent—there are specific steps you should take.
Contact your healthcare provider immediately to discuss the risks associated with the recall and available treatment options.
Do not remove or stop using the device without first seeking medical advice.
Ask for recall documentation or medical monitoring options. Also, gather any available information about the recall from the FDA and the device manufacturer’s websites.
Document your symptoms, treatments, and expenses. Capture as complete a picture as possible about the impact the defective stent is having on your health, your finances, your life, and the lives of your loved ones.
Who’s responsible for a defective medical device?
Product liability laws protect patients harmed by unsafe medical devices. While every situation is different, manufacturers, distributors, or medical providers—or a combination of these—could be liable for the negative impact a defective device can have on a patient and their family.
The product liability attorneys at Tiano O’Dell have extensive experience in holding negligent corporations and the medical profession accountable for harming patients and their livelihoods.
We can discuss with you the particulars of your situation and determine how best to help you attain any financial reimbursements or damages you may be owed.
How a West Virginia defective medical device lawyer can help
An experienced attorney, like a member of the Tiano O’Dell team, can prove an invaluable partner if you have a defective medical device case. The attorney can investigate recalls, navigate medical evidence, and help you secure compensation.
The product liability attorneys at Tiano O’Dell offer accessible legal representation. We work on a contingency-fee basis, meaning we don’t get paid unless we recover money for you. There are also no upfront costs when you work with us.
We’re here to help
Defective vascular stents are a serious safety concern. Patients implanted with them have rights and options available to them—and they need to know what they are.
If you or a loved one has suffered complications from a recalled vascular stent, contact Tiano O’Dell, PLLC, today for a free consultation.
You can contact us online or call (304) 915-0823.
