Bard PowerPICC Intravascular Catheter Leaks Linked to Reports of Serious Injuries: FDA

Reports indicate material fatigue is causing the catheters to crack and fail.

As Bard currently faces a growing number of PowerPort catheter lawsuits being filed over material failures, fractures and migrations, federal health officials are now warning that a defect in the manufacturer’s PowerPICC catheters can cause the devices to fail, which has resulted in at least 10 injuries to date.

The U.S. Food and Drug Administration (FDA) issued an early alert warning on April 18, indicating that certain Bard Access Systems PowerPICC Intravascular Catheters should be removed from use because they are prone to material fatigue, resulting in a serious risk to patients.

Bard PowerPICC catheters are designed to deliver intravenous therapy directly into the central venous system. It also supports high-pressure contrast media injections for use with X-rays or ultrasounds and allows for central venous pressure monitoring during short- or long-term procedures.

However, the manufacturer has identified a defect in the catheters that is leading to an increase in its material to weaken, which can cause leaks. An investigation has indicated that this weakness occurs due to the material resin used in manufacturing the catheter’s tubing, most often leading to transverse/circumferential cracks in the catheter’s body.

These problems closely mirror allegations raised in more than 1,200 Bard PowerPort lawsuits, which involve similar catheter failures caused by the use of barium sulfate to enhance visibility under imaging scans.

In each of the lawsuits, plaintiffs claim the additive compromises the integrity of the port’s polyurethane material, making it prone to cracking, breaking, or migrating inside the body. As a result, many patients have suffered severe infections, vascular injuries, and the need for revision surgery, prompting a series of lawsuits to be filed against the manufacturer.

In the latest FDA warning, officials indicate that as a result of the Bard PowerPICC leaks caused by these cracks, patients face severe risks of fluids leaking into surrounding tissues, which can cause discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. 

To date, at least 10 people have suffered injuries in connection with the PowerPICC catheters failing during infusions.

The alert involves BD and its subsidiary company Bard Access Systems PowerPICC Intravascular Catheters, including the 4 Fr. Single Lumen Power PICC, SOLO and non-SOLO versions.

BD sent out Urgent Medical Device Product Recall notices on March 11, 2025, calling for healthcare providers to review their inventory to see if PowerPICC catheters are being used by patients and to consider alternative options for patient infusions.

Devices that are not in use should be removed from where they are used or sold. For devices that are in-use, healthcare providers should follow updated instructions for use.

FDA PowerPICC Recommendations

The FDA advises healthcare providers to monitor PowerPICC catheters for signs of material fatigue, such as infusion pain, arm swelling (unrelated to DVT), blood withdrawal issues, or leakage at the insertion site. If damage is suspected, infusion should be stopped immediately, the catheter inspected, and removed if compromised. Alternate intravascular access should then be established.

To reduce failure risks, providers should use adhesive-backed securement systems (e.g., StatLock, Tegaderm) rather than compression devices, and insert the catheter close to the zero-centimeter mark.

If no damage is present, no action is needed. The FDA does not recommend proactive removal unless damage is evident. This alert is part of a new pilot program to warn the public of device risks before formal recalls.

Customers with questions or problems can contact BD about the device issue at 844-823-5433. Customers are also urged to report any adverse side effects linked to the use of the Bard PowerPICC catheters to the FDA’s MedWatch Adverse Event Reporting System. 

Bard PowerPort Lawsuits Over Catheter Failures

Following the recent FDA alert about safety concerns with Bard’s PowerPICC catheters, attention is also intensifying around the company’s PowerPort devices, which have been the subject of growing litigation over similar material failures the past few years.

The Bard PowerPort is a totally implantable vascular access device (TIVAD) used to deliver medications, such as chemotherapy, directly into a patient’s bloodstream. It consists of a port chamber implanted under the skin and a polyurethane catheter that connects to a central vein.

However, the devices have been linked to a growing number of PowerPort fracture, migration and infection injuries in recent years, prompting individuals to pursue compensation through Bard PowerPort lawsuits. 

Given the common questions of fact and law raised in each of the Bard PowerPort lawsuits, the claims were centralized in a federal multidistrict litigation (MDL), which is currently being overseen by U.S. District Judge David G. Campbell in the District of Arizona. The litigation includes over 1,000 product liability lawsuits brought by individuals nationwide who suffered infections, catheter fractures and migration injuries after receiving Bard PowerPort implants.

To evaluate how juries may respond to the evidence and testimony that will be repeated throughout the litigation, the court established a bellwether trial process. In December 2023, the parties selected an initial pool of 24 cases. That group was narrowed to 15 lawsuits eligible for early trials, and by late April 2025, six final cases are expected to be selected for bellwether preparation.

According to a recent Case Management Order, the final PowerPort bellwether selections must be submitted to the court by April 28, 2025. These cases will then proceed through expert discovery and trial preparation over the remainder of the year. While the outcomes will not be binding on other claims, the jury verdicts in these test trials will play a critical role in shaping potential PowerPort settlement negotiations and may influence whether Becton Dickinson opts to resolve the litigation or face hundreds of individual trials nationwide.