AXIOS Stent Injury and Wrongful Death Lawsuit Lawyers

Patients and Families Explore Legal Options Following Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System Recall

The U.S. Food and Drug Administration has classified the recall of certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems as a Class I recall, the most serious type of medical device recall. This classification means that continued use of the affected products may cause serious injury or death. When a recall reaches this level, it signals that the risks are not theoretical. They are real, documented, and potentially life-threatening.

The recall involves specific models of the AXIOS stent system manufactured by Boston Scientific. According to public reports, the issue centers on difficulties with stent deployment and expansion at the time of placement. When the device fails to deploy properly, doctors may be forced to extend the procedure, replace the device, or perform additional endoscopic or surgical intervention. In certain cases, the failure has resulted in severe complications.

As of late December, there were 167 reported serious injuries and three deaths associated with this issue. For patients who underwent procedures involving pancreatic pseudocysts, walled-off necrosis, or gallbladder drainage, these numbers are deeply concerning. When a device meant to relieve suffering instead creates additional harm, accountability becomes critical.

What Parker Waichman LLP Found

• The recall has been classified as Class I, indicating the highest level of risk.
• Deployment failures reportedly led to 167 serious injuries and three deaths.
• The issue arises during stent placement, potentially requiring additional surgical intervention.
• Hospitals were instructed to remove affected devices from inventory immediately.
• Patients harmed during deployment may have grounds to pursue a product liability claim.

What Is a Medical Device Recall?

A medical device recall occurs when a manufacturer or regulatory authority determines that a product poses a safety risk. Recalls can involve correcting the device, updating instructions, or removing the product from circulation. In more serious situations, devices are pulled from hospitals and distribution centers entirely.

The FDA assigns recall classifications based on risk:

• Class I Recall: A reasonable probability that the device will cause serious adverse health consequences or death.
• Class II Recall: A device may cause temporary or medically reversible health consequences.
• Class III Recall: A device is unlikely to cause adverse health consequences but violates FDA regulations.

The AXIOS stent recall has been designated as Class I. This signals that the potential for harm is severe. Hospitals and distributors were instructed to immediately stop using and distributing affected devices and to remove them from inventory.

For patients, a recall does not automatically mean a device implanted in the body must be removed. In this case, the reported issue occurs during deployment, not after successful implantation. However, those who experienced complications during placement may have legal grounds to pursue a claim.

What Is an FDA Early Alert?

An Early Alert is issued when the FDA becomes aware of a potentially high-risk medical device issue before it has completed its full review and classification. It is designed to notify healthcare providers and the public as quickly as possible when there may be significant danger.

In this matter, the FDA first issued an Early Alert communication in January. By February 25, the agency formally classified the situation as a Class I recall. This progression shows how safety investigations can evolve as more data becomes available.

Early Alerts are especially important in medical device cases because they may provide patients and physicians with critical information while investigations are ongoing. However, once a recall is finalized at the highest level, the seriousness of the situation is confirmed.

Which Devices Are Affected?

The recall involves certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems identified by specific Unique Device Identifiers (UDIs) and UPN numbers. These devices are used in advanced endoscopic procedures for:

• Drainage of pancreatic pseudocysts
• Drainage of walled-off necrosis
• Gallbladder drainage in patients with acute cholecystitis who are not surgical candidates

The issue does not affect stents that were successfully implanted and functioning as intended. The reported problem occurs during deployment. If the stent fails to expand or the first flange does not deploy correctly, physicians may need to:

• Exchange the device
• Perform additional endoscopic maneuvers
• Conduct surgical removal
• Close a puncture site created during insertion

These added steps can increase procedure time, raise the risk of bleeding or infection, and create life-threatening complications.

Understanding the Reported Injuries and Deaths

When a stent fails to deploy correctly, the consequences can escalate rapidly. Patients undergoing pancreatic or gallbladder drainage procedures are often already in fragile health. Prolonged procedures can increase anesthesia risk, blood loss, and the potential for organ injury.

In cases where the flange fails to expand, physicians may need to retrieve the device and close the access site. That process can introduce additional trauma and infection risk. Internal bleeding, perforation, sepsis, and other serious complications may follow.

The 167 serious injuries and three reported deaths associated with this issue highlight the gravity of deployment failures. While each case has unique medical facts, the common factor is a device intended to provide therapeutic drainage that instead complicated treatment.

What Is a Unique Device Identifier (UDI) and Why It Matters

The Unique Device Identifier system allows regulators, hospitals, and patients to identify specific medical devices from manufacturing through implantation. Each device is assigned a code that can be traced through the FDA’s database.

The UDI system improves safety monitoring by allowing adverse event reports to be tied to exact product batches and models. In recall situations, this system enables healthcare facilities to determine quickly whether they possess affected inventory.

For patients pursuing legal action, UDI information may help establish whether a recalled device was used during their procedure. Medical records often contain product identifiers that can confirm device involvement.

Legal Claims Arising from Medical Device Recalls

When a medical device causes harm, injured patients may pursue legal claims under several theories:

• Defective Design: The product’s design created unreasonable risk.
• Manufacturing Defect: A production flaw caused the device to malfunction.
• Failure to Warn: Inadequate instructions or warnings about risks.
• Negligence: Failure to exercise reasonable care in testing or monitoring the device.

In recall cases, internal company communications, testing data, and adverse event reports may become central evidence. Plaintiffs may seek compensation for:

• Medical expenses
• Additional surgical procedures
• Pain and suffering
• Lost wages
• Wrongful death damages in fatal cases

Each state has statutes of limitation that restrict how long a patient has to file a lawsuit. Acting promptly is essential to preserve rights.

AXIOS Device Lawsuit FAQs

What if my stent was successfully implanted and I have no complications?
The reported issue involves deployment at the time of placement. If your device was implanted without incident and you are not experiencing complications, your physician will likely recommend continued monitoring under standard care. However, if you later develop symptoms, you should seek medical evaluation.

How do I know if a recalled AXIOS device was used during my procedure?
Your medical records should identify the specific device used, including its model or Unique Device Identifier. You have the right to request copies of your records from the hospital or physician who performed the procedure.

Can I file a lawsuit if the device caused additional surgery or prolonged hospitalization?
Yes. If the stent malfunction led to extended procedures, surgical intervention, infection, or other injuries, you may have grounds to pursue compensation. A legal review can determine whether the facts support a product liability claim.

What compensation may be available in a medical device lawsuit?
Compensation may include past and future medical expenses, lost income, diminished earning capacity, pain and suffering, and in fatal cases, wrongful death damages. The value of a claim depends on the severity of injuries and long-term impact.

Is there a deadline to file a claim?
Every state has time limits known as statutes of limitation. Missing these deadlines can prevent recovery. Because recall classifications and injury discovery dates can affect timing, early evaluation is critical.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

If you or a loved one experienced complications during placement of an AXIOS Stent or Electrocautery-Enhanced Delivery System, you may have legal options. Parker Waichman LLP represents individuals nationwide who have been harmed by dangerous medical devices. The firm offers a free consultation to evaluate your potential claim.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation and to discuss your case. There is no obligation, and you pay nothing unless there is a recovery. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.