Is There a Recall of Bard PowerPort Devices?

When a medical device fails and causes serious harm, patients naturally want to know whether there’s been an official recall by the U.S. Food and Drug Administration (FDA). However, there has been no overarching recall of Bard PowerPort devices, despite numerous reports of serious complications. The absence of a full-scale recall does not mean these devices are completely safe, nor does it prevent you from seeking legal recourse if you have been injured.

The FDA History of Bard PowerPort Devices

In 2015, Bard made a change to their PowerPort line by introducing a new catheter material called Chronoflex AL. This polyurethane blend was designed to provide enhanced durability and flexibility. Unfortunately, the material has proven to be unstable, causing the catheter to develop microfractures and weak points that make it prone to breaking inside the body.

Bard PowerPort devices with Chronoflex AL were cleared for use through the FDA’s 510(k) process. This pathway doesn’t require extensive clinical trials. Instead, manufacturers only need to show their device is substantially equivalent to one already on the market—meaning it functions similarly without introducing new safety concerns. But there are safety concerns with the PowerPort, and the device remains on the market.

Known Defects and Complications with Bard PowerPorts

The Bard PowerPort has been associated with several complications that have led to numerous lawsuits:

• Catheter Fracture: The device’s material composition makes it prone to breaking under stress, with fragments potentially lodging in the vascular system. These broken pieces can damage blood vessels or travel through the bloodstream, creating risks of pulmonary embolism or stroke.
• Catheter Migration: This occurs when the device or its components shift from their original position after implantation. Migration can happen due to material brittleness and may result in loss of functionality, requiring additional surgery to reposition or remove the device.
• Infections: When the device fractures or degrades, bacteria can enter through compromised areas. This can lead to infections at the port site that may spread into the bloodstream and cause sepsis. These infections often require aggressive antibiotic treatment or surgical device removal.
• Thrombosis: Blood clot formation can occur due to irregular surfaces and material degradation that disrupt normal blood flow. Blood clots can block vessels, travel to the lungs, or cause long-term damage requiring anticoagulation therapy or surgical intervention.

What Are Your Rights After Being Hurt by a Bard PowerPort?

If you have suffered complications from a Bard PowerPort, you have the right to pursue legal action against the manufacturer. Current Bard PowerPort lawsuits allege that design defects and inadequate warnings contributed to patient injuries. These cases seek compensation for medical expenses, pain and suffering, lost income, and other damages related to device failure.

Taking the right steps can protect both your health and legal rights. Here’s what to do:

• Seek immediate medical attention for any symptoms like chest pain, fever, swelling, or difficulty breathing, and keep detailed records of all treatments and diagnoses.
• Document everything related to your device, including implantation records, model information, complication dates, and photographs of visible injuries.
• Consult with a Bard PowerPort lawsuit attorney who can explain your legal options.

An attorney can evaluate whether your injuries are connected to known defects, help you understand the full scope of your damages, and pursue compensation for medical expenses, pain and suffering, lost wages, and more. Reach out to a Bard PowerPort lawsuit attorney today to explore your legal options and take the first step toward recovery.