Centerline Biomedical IOPS Guidewire ATW-2 Injury Lawsuit Lawyers

National Legal Representation for Patients Harmed by Defective Guidewires Recalled by Centerline Biomedical

Patients undergoing vascular procedures expect their medical devices to meet the highest safety standards. Unfortunately, a recent recall by Centerline Biomedical has revealed a serious safety issue involving its IOPS Guidewire ATW-2. According to the U.S. Food and Drug Administration (FDA), the coating on these guidewires can peel off and be left inside the patient’s body during a procedure. This defect could lead to the need for emergency surgical intervention, prolonged hospitalization, or, in the worst-case scenario, death.

Although no deaths or serious injuries have been officially reported to date, the FDA has classified the recall as a Class I—the most severe recall category, reserved for defects with the potential to cause significant harm or fatal outcomes. These guidewires were distributed to facilities across at least eight states and are commonly used in delicate procedures where catheter placement is guided through sensitive vascular structures. When part of the device is unintentionally retained in the patient, it may trigger a dangerous medical emergency.

If you or a loved one has experienced complications following a procedure involving the Centerline IOPS Guidewire ATW-2, it is critical to understand your legal rights. Affected patients may be eligible to pursue financial compensation through a defective medical device lawsuit. Parker Waichman LLP is actively investigating injury claims nationwide linked to this recall and offering free consultations to those who may have been harmed.

What Is the Centerline IOPS Guidewire and Why It Was Recalled

The Centerline IOPS Guidewire ATW-2 is designed to assist in catheter placement during vascular surgeries. Unlike traditional guidewires, this device is sensor-enabled and interacts with a real-time computer mapping system. The goal is to help surgeons navigate the vascular system with precision using advanced intraoperative positioning. However, the guidewire’s coating has been found to delaminate—a process in which the outer layer peels or separates—during use.

When delamination occurs, fragments of the device’s coating can break off and remain inside the patient. These foreign materials can lead to severe complications, including:

• Internal blockages or embolisms
• Vascular damage
• Blood clot formation
• Infection
• Extended surgical time or additional follow-up operations
• Long-term internal injuries or scarring

In April, Centerline Biomedical issued an urgent recall notice, instructing healthcare facilities to remove affected devices from use and return them to the manufacturer. While only 80 units were distributed commercially, they were spread across eight different states, posing a significant risk to patients in those regions.

This is Centerline’s first entry in the FDA’s device recall database. While the company has removed the faulty guidewires from circulation, patients who were already treated with them may still be at risk and unaware of potential complications arising from the use of the recalled product.

Understanding the Legal Implications of Medical Device Failure

Medical device manufacturers are legally obligated to ensure their products are safe and function as intended. When a product reaches the market with a serious defect—especially one that requires surgical intervention to correct—it can open the door to legal claims under product liability laws.

In the case of the Centerline IOPS Guidewire ATW-2, the device was approved under the FDA’s 510(k) process, which allows new devices to reach the market based on substantial equivalence to previously approved devices. While this process expedites access to innovative technology, it can also result in less rigorous safety testing, increasing the risk that defective products are introduced to patients.

Victims harmed by defective medical devices may be entitled to compensation for:

• Medical expenses related to injury or additional surgery
• Lost wages due to extended recovery
• Pain and suffering
• Permanent physical damage or disfigurement
• Emotional trauma and reduced quality of life

Even if no immediate injury occurred, patients who received treatment using a recalled Centerline guidewire may be entitled to medical monitoring or preventative care paid for by the manufacturer. Consulting with an experienced product liability attorney is the most reliable way to determine your legal options.

Why the FDA Classified This Recall as Class I

The FDA classifies medical device recalls into three categories: Class I, Class II, and Class III. A Class I recall, like the one involving the Centerline guidewire, is issued only when there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

This elevated classification reflects the fact that retained fragments from medical devices can have devastating effects on a patient’s health. In vascular procedures, even small foreign objects can cause major complications. The nature of these surgeries often means that risks like internal bleeding, clotting, or embolism can escalate quickly and without warning.

The recall stems from concerns that the defective coating may not be visible to the surgeon once inside the body. This lack of visibility increases the chances that loose fragments could go undetected during the procedure, setting the stage for dangerous post-surgical complications.

When the FDA takes the step of publishing a Class I recall, it signals that patients who received the product should be closely monitored, and those harmed have a legitimate basis to pursue compensation under U.S. civil law.

Who May Be Eligible to File a Centerline Guidewire Lawsuit

Anyone who underwent a vascular procedure involving the Centerline IOPS Guidewire ATW-2 may be eligible to file a lawsuit if they suffered complications due to retained coating fragments or were required to undergo additional surgery to remove materials from the guidewire.

You may be eligible to file a lawsuit if you:

• Had a vascular procedure between the time the defective devices were distributed and recalled
• Were informed post-operatively that part of the device was retained
• Experienced unexplained medical complications after the procedure
• Required a second surgical procedure to remove a foreign object
• Suffered from infections, embolisms, or internal blockages linked to a retained object
• Lost wages or incurred medical bills due to corrective treatment

Family members of patients who died following such complications may also be able to file wrongful death claims. Our legal team at Parker Waichman LLP can help evaluate your case, determine whether a recalled Centerline guidewire was used, and assist you in holding the manufacturer accountable.

Legal Representation for Victims Nationwide

Our firm is known for handling complex medical device litigation. We have successfully represented individuals harmed by faulty surgical tools, implants, and monitoring systems. When a product like the Centerline guidewire is recalled due to risks of serious injury, our job is to help victims recover the compensation they need to heal and protect their future.

The sooner you contact an attorney, the better your chances of preserving evidence and ensuring your rights are protected. Many states have strict statutes of limitations on personal injury and product liability claims. If you suspect your procedure involved a defective Centerline guidewire—or if you’ve already experienced health complications—do not wait.

Contact Parker Waichman LLP For a Free Case Review

If you or someone you love suffered complications after a vascular procedure involving a Centerline IOPS Guidewire ATW-2, you may be entitled to compensation for your injuries. Our national legal team is actively reviewing claims tied to this FDA Class I recall and offering free consultations to affected patients and families.

Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) to speak with a medical device injury attorney. We can help you understand your rights, assess your case, and hold the manufacturer accountable for putting your health at risk. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.