As Bard Access Systems faces mounting legal pressure over their PowerPort implantable catheters, a new wave of safety concerns has emerged surrounding another one of their vascular access catheters. On April 18, 2025, the U.S. Food and Drug Administration (FDA) issued an early safety alert regarding Bard PowerPICC Intravascular Catheters, warning that certain models may be prone to material fatigue, which can lead to cracking, leakage, and serious patient harm.
The devices are used to deliver intravenous therapy directly into a patient’s central venous system and are particularly vulnerable due to a defect linked to the resin material used in the catheter tubing. According to Bard’s own investigation, the defect can result in transverse or circumferential cracks, ultimately causing the catheter to fail during use.
At least 10 patient injuries have been reported in connection with failed PowerPICC catheters. The FDA warns that these failures can result in infusion leaks into surrounding tissue, leading to complications such as:
- Discomfort and phlebitis
- Bleeding
- Air and foreign body embolism
- Infection
- Therapy interruptions
This warning involves multiple versions of the PowerPICC device, including the 4 Fr. Single Lumen PowerPICC, SOLO, and non-SOLO models.
Urgent Recall and Recommendations
Becton Dickinson (BD), the parent company of Bard, issued Urgent Medical Device Product Recall notices on March 11, 2025, advising healthcare providers to:
- Review current inventory for affected devices
- Remove unused PowerPICC catheters from circulation
- Consider alternative devices for ongoing or future infusions
- Follow new instructions for use if a catheter is already in place
The FDA does not recommend proactively removing PowerPICC catheters unless damage is evident. Instead, it urges healthcare professionals to watch for signs of catheter fatigue, such as:
- Infusion site pain
- Arm swelling unrelated to DVT
- Blood withdrawal difficulty
- Visible or suspected leakage
Other Bard PowerPort Lawsuits
The FDA alert draws striking parallels to the growing litigation surrounding Bard’s PowerPort implantable devices, which have been linked to similar issues involving material degradation, fractures, and device migration.
Over 1,200 lawsuits have been filed against Bard and BD, alleging that the use of barium sulfate to enhance radiopacity compromised the structural integrity of PowerPort catheters. Plaintiffs claim that the defective material design has led to:
- Severe infections
- Vascular damage
- Device migration requiring revision surgery
These allegations have culminated in a federal multidistrict litigation (MDL) in the U.S. District Court for the District of Arizona, overseen by Judge David G. Campbell. As of April 2025, over 1,000 cases are pending in the MDL, and a bellwether trial process is well underway.
What Patients and Providers Should Know
Patients currently using a PowerPICC or PowerPort catheter should consult their healthcare providers for guidance, especially if experiencing unexplained symptoms near the insertion site or during infusions.
Healthcare providers are encouraged to:
- Monitor for signs of failure
- Use best practices for catheter securement and placement
- Report any adverse events to the FDA MedWatch system
Minnesota Catheter Port Injury Attorneys
The Catheter Port injury attorneys at Goldenberg Lauricella continue to fight for clients who have been harmed by medical device manufacturers. We are currently investigating catheter port injury cases. Contact us today at 855-333-4662 for a free case consultation.