Boston Scientific Innova Stent Lawsuit | 2025 Latest Updates

Boston Scientific Innova Stent Lawsuit Overview

The Boston Scientific Innova Stent lawsuits center on the self-expanding stent system’s failure to deploy or only partially deploy during surgical procedures. Primary allegations against Boston Scientific include manufacturing defects that led to serious medical complications, such as vessel wall injury, increased procedure time, and/or emergency surgery to remove the partially deployed stent. The FDA received complaints about these deployment failures, which prompted a Class I recall – the most serious type of recall. This recall affected 505 devices distributed globally, primarily in international markets outside the U.S. The recall was initiated due to reports of no deployment or partial deployment, which could cause serious adverse health consequences or death.

Latest Boston Scientific Innova Stent Lawsuit Updates

November 7, 2017 – Boston Scientific issued a recall affecting select Eluvia and Innova stents, citing deployment and delivery issues that may factor into ongoing product liability lawsuits [1].June 16, 2011 – Boston Scientific recalled its Innova SFA stent system across international markets following reports of deployment issues, an action likely to influence legal claims from patients and providers. June 15, 2011 – The FDA classified Boston Scientific’s recall of the Innova Self-Expanding Stent System as Class I, announced publicly by June 17, due to potential failure to deploy or partial deployment during the implant procedure, risking vessel wall injury, increased procedure time, or emergency surgery to remove partially deployed stents.May 13, 2011 – Boston Scientific sent a recall notification letter to overseas customers for the Innova Self-Expanding Stent System, later classified as a Class I recall by the FDA on June 15, 2011.March 2011 – Boston Scientific’s Innova Self-Expanding Stent received European approval, with sales beginning the following month in Europe and other countries that follow European device approval regulations.

FDA Reports and Statistics

The FDA classified the Boston Scientific Innova Stent recall as a Class I event, which is the most serious type of recall notification. The recall included 505 devices distributed globally outside the U.S., as the Innova Stent was not yet approved for U.S. sale. According to Q1 2011 reports, Boston Scientific’s peripheral interventions business, including the newly launched Innova Stent, reported sales of $176 million, approximately nine percent of the company’s $1.925 billion total sales.Due to the fact that deployment failures typically occur during the surgical implant procedure, already implanted stents were not included in this recall.

Boston Scientific Innova Stent Injuries & Side Effects

The defective Innova stents have been associated with several serious complications that can occur during or after the implantation procedure.

• Vessel Wall Injury: Partial deployment can damage arterial walls, potentially leading to bleeding or thrombosis
• Emergency Surgery: To remove partially deployed stents, increasing risk of complications
• Increased Procedure Time: Leading to extended anesthesia and greater surgical risks
• Blood Flow Obstruction: May occur if the stent fails to properly expand

Do You Qualify for a Boston Scientific Innova Stent Lawsuit?

You may qualify for a Boston Scientific Innova Stent lawsuit if:

• You received a Boston Scientific Innova self-expanding stent system that was subject to the 2011 recall
• You experienced complications such as vessel wall injury or required emergency surgery to remove a partially deployed stent
• The injuries required additional medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the Boston Scientific Innova stent

Evidence Required for a Boston Scientific Innova Stent Lawsuit

To successfully pursue a Boston Scientific Innova Stent lawsuit, you will need to provide:

• Medical records documenting the implantation of a Boston Scientific Innova stent
• Documentation of complications or additional surgeries related to stent deployment failure
• Proof that your device was included in the recalled lot numbers
• Medical expert testimony establishing a link between your injuries and the defective stent

Damages You Can Recover

By filing a Boston Scientific Innova Stent lawsuit, you may be able to recover compensation for:

• Medical expenses, including costs for emergency surgery and ongoing care
• Lost wages due to time off work for recovery
• Pain and suffering associated with complications and additional procedures
• Punitive damages in cases where gross negligence can be established

Boston Scientific Innova Stent Recall Information

In May 2011, Boston Scientific initiated a Class I recall of its Innova self-expanding stent system. The recall affected 505 devices globally, primarily in international markets outside the U.S., where the product was marketed after receiving CE Mark approval in March 2011. The FDA posted the recall notice in June 2011. The recall was prompted by reports of no deployment or partial deployment of the stents during procedures, which could lead to serious health issues such as vessel wall injury, increased procedure time, and/or emergency surgery to remove the partially deployed stent. Class I recalls are the most serious type, indicating a reasonable probability that the product could cause serious adverse health consequences or death. The recall did not affect stents already implanted, as the issue occurred during stent delivery.

Statute of Limitations for Boston Scientific Innova Stent Lawsuits

The statute of limitations for filing a Boston Scientific Innova Stent lawsuit varies by state, typically ranging from 1-3 years from the date you discovered or should have reasonably discovered your injury. Given these time constraints, it’s crucial to consult with an attorney as soon as possible to ensure your legal rights are protected.

FAQs

1. What exactly was the problem with Boston Scientific Innova Stents?

The Boston Scientific Innova stent systems had a defect that caused them to fail to deploy or only partially deploy during surgical procedures, potentially resulting in vessel wall injury, increased procedure time, and/or emergency surgery to remove the partially deployed stent.

2. How do I know if my stent was part of the recall?

Already implanted stents that were functioning properly were not included in the recall since the deployment failure typically occurred during the surgical implant procedure. Your medical provider can check if the stent used in your procedure was part of the recalled lots.

3. Can I sue for wrongful death if a loved one died due to complications from a defective Innova stent?

Yes, if a loved one died due to complications from a defective Innova stent, you may be able to file a wrongful death lawsuit seeking compensation for funeral expenses, loss of income, loss of companionship, and other related damages.

4. What are the signs that my Innova stent may be defective?

Signs that your Innova stent may be defective include chest pain, shortness of breath, sudden numbness or weakness, swelling in the legs, or any symptoms of a heart attack or stroke. If you experience any of these symptoms, seek medical attention immediately.

5. Can I seek compensation for emotional distress after experiencing complications from a defective Innova stent?

Yes, you may be able to seek compensation for emotional distress if complications from a defective Innova stent cause significant psychological harm, such as anxiety, depression, or post-traumatic stress disorder (PTSD).

6. What is peripheral artery disease (PAD) and how does it relate to the Innova stent?

PAD occurs when peripheral arteries of the pelvis or legs are significantly narrowed. The Boston Scientific Innova stent was designed to treat this condition by keeping narrowed arteries open and maintaining blood flow through the vessels.

7. How much compensation can I expect from a Boston Scientific Innova Stent lawsuit?

Compensation varies based on the severity of injuries, medical expenses, lost wages, and other factors. Settlements may range from thousands to millions of dollars depending on the specific circumstances of your case.Related article: Cook Zilver PTX Stent Class Action LawsuitContact us today to speak to an experienced product liability attorney to learn more about your legal rights.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for injuries related to defective Boston Scientific Innova stents. The statute of limitations restricts the time you have to file a claim, typically only 1-3 years from the date of injury or discovery of injury, depending on your state.Our firm offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees to begin working on your claim
• Payment only if we win your case

Don’t delay seeking the compensation you deserve. Contact us today to speak with an experienced product liability attorney and learn more about your legal rights.

Do I have a Boston Scientific Innova Stent Recall Lawsuit?

The Product Liability and Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Boston Scientific Innova stent recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.References:[1] https://www.drugdeliverybusiness.com/boston-scientific-recalls-certain-sizes-eluvia-innova-stents/