How To File a Centerline Biomedical IOPS Guidewire Injury or Wrongful Death Lawsuit

Legal Help for Patients Harmed by Recalled Centerline IOPS Guidewires Used in Vascular Procedures

On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall—its most severe designation—for specific batches of Centerline Biomedical’s IOPS Guidewires used in vascular procedures. The recall applies to lot 2404-2005, after it was discovered that the outer coating of these guidewires can delaminate during use. When this occurs, part of the coating may remain inside the patient’s body, leading to serious risks.

Patients undergoing vascular procedures rely on safe, precision-engineered tools to reduce complications. The Centerline IOPS Guidewire is intended to assist physicians with real-time navigation inside the body, particularly in the descending aorta. However, when components of the device separate and remain inside the vascular system, the patient can experience dangerous complications that may include:

• Extended surgical time
• Emergency secondary procedures
• Vascular damage
• Infections
• Long-term disability
• Death

Although no confirmed injuries have been reported at the time of the recall, the FDA’s Class 1 designation signals an imminent risk of serious injury or death. If you or someone you love experienced unexplained complications following a vascular procedure involving a Centerline IOPS Guidewire, you may be entitled to significant financial compensation. Our national civil litigation law firm is currently investigating claims and can guide you through the next steps.

What Went Wrong: Delamination of the Guidewire Coating

The FDA recall centers around a critical manufacturing defect: the potential for the guidewire’s coating to peel or fragment during insertion. This process, known as delamination, causes tiny fragments of the guidewire to break off and remain inside the body. These retained fragments can obstruct blood vessels, migrate to other parts of the body, or become a source of infection and inflammation.

Retained fragments from a delaminated medical device may not be detected until after the patient begins experiencing complications—sometimes days or weeks after surgery. In many cases, these complications require additional surgical interventions to locate and extract the foreign material. Each added procedure increases the risk of infection, trauma, and long-term damage to the patient’s health.

These risks are particularly troubling given the nature of the IOPS Guidewire. Used during endovascular procedures, the device is inserted into delicate vascular pathways, where any foreign object could cause devastating effects on circulation or organ function.

If you or a loved one suffered complications that required prolonged hospitalization, emergency intervention, or follow-up surgery after a vascular procedure, the Centerline recall could be the cause—and legal accountability may be possible.

Legal Grounds for a Centerline Guidewire Lawsuit

Medical device manufacturers have a legal duty to ensure that their products are safe, effective, and properly manufactured. When a product is recalled due to a design flaw or manufacturing defect—especially one as serious as coating delamination—the manufacturer may be held liable for resulting harm.

You may have grounds to file a personal injury or wrongful death lawsuit if:

• You or your family member underwent a procedure using a Centerline IOPS Guidewire (lot 2404-2005).
• You suffered complications, including extended hospital stays, additional surgeries, infections, or internal damage.
• A retained medical device or foreign object was identified in your body following the procedure.
• A loved one died as a result of complications stemming from their vascular procedure.

Potential claims include:

• Product liability: Holding the manufacturer responsible for releasing a defective product.
• Medical negligence: If a healthcare provider failed to identify or report the use of a recalled product.
• Wrongful death: If complications from the guidewire led to a patient’s death.
• Failure to warn: If the risks were not clearly disclosed or the provider continued using the product after the recall notice.

Our legal team will help identify all liable parties, which may include not only Centerline Biomedical, but hospitals, distributors, or other companies involved in the supply chain.

How the Recall Was Handled—And What That Means for Your Case

Centerline Biomedical first contacted affected facilities on April 11, 2025, urging providers to review their inventory and isolate any impacted guidewires from lot 2404-2005. The company also instructed facilities to coordinate replacement through their account managers and report any adverse events to the FDA’s MedWatch program.

Despite these measures, the recall’s seriousness means that even brief usage of a defective guidewire could result in significant harm. Additionally, the recall does not erase liability for any injuries already caused. Medical devices approved by the FDA still carry strict safety requirements under federal law, and manufacturers can be held accountable for preventable injuries or deaths resulting from faulty products.

If you were not informed of the recall—or only learned of it after suffering complications—it may indicate that a healthcare provider or facility failed in their responsibility to notify you. This could also strengthen your legal case.

Steps to File a Centerline Biomedical IOPS Guidewire Lawsuit

Filing a lawsuit against a medical device manufacturer can feel overwhelming, especially when you’re recovering from a serious medical complication. That’s why our law firm handles every aspect of the legal process on your behalf—from medical investigation to filing, litigation, and settlement negotiation.

Here’s how to begin:

1. Confirm Procedure Details: If you underwent a vascular procedure involving real-time positioning technology, contact the hospital or medical facility and request your surgical records. Determine whether a Centerline IOPS Guidewire was used and whether it matches lot 2404-2005.
2. Document Your Complications: Gather all relevant medical records, including post-operative reports, infection diagnoses, scans or X-rays, and any records of follow-up procedures. These will be critical in building your case.
3. Consult With a Product Liability Lawyer: Once you have your documentation, speak with an attorney who understands complex medical device litigation. At Parker Waichman LLP, our legal team will conduct a free, thorough review of your case.
4. File a Claim: If your case qualifies, we will file a lawsuit on your behalf seeking compensation for medical expenses, lost wages, pain and suffering, and—if applicable—wrongful death damages.

Who Can File a Wrongful Death Claim

If a family member died after undergoing a vascular procedure where a Centerline IOPS Guidewire was used, and that death was related to surgical complications or retained materials, you may be eligible to pursue a wrongful death lawsuit.

Eligible family members may include:

• Spouses
• Children
• Parents
• Legal representatives of the estate

Wrongful death claims can seek compensation for funeral costs, loss of companionship, loss of income, and pain endured by the deceased prior to death. Our legal team will investigate the medical history, procedural documentation, and any evidence of retained guidewire fragments to build a strong case for your family.

Parker Waichman LLP Is Accepting IOPS Guidewire Lawsuits Nationwide

Our firm has a long history of handling defective medical device cases with precision and determination. We understand the legal, medical, and emotional challenges families face after suffering from a dangerous product. The recall of Centerline’s IOPS Guidewire poses real and life-threatening risks, and victims deserve justice.

We are now accepting injury and wrongful death claims nationwide related to this recall. Time limits apply in these cases, so it’s important to act quickly. Our team offers free consultations to evaluate your claim and explain your legal rights without pressure or obligation.

Contact Parker Waichman LLP For a Free Case Review

If you or someone you love was harmed by a Centerline IOPS Guidewire during a vascular procedure, legal action may provide the path to justice and financial recovery. These devices were recalled due to a serious defect that poses life-threatening risks, and your case deserves immediate attention.

Our national law firm is now accepting injury and wrongful death cases related to Centerline’s recalled guidewires. Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. We will investigate your case at no cost to you. There are no legal fees unless we win compensation on your behalf.