FDA issues alert on intravascular catheters after 10 serious injuries
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to a high-risk issue involving certain PowerPICC Intravascular Catheters, manufactured by BD and its subsidiary Bard Access Systems. A problem with the resin material in some of the devices can cause them to lose structural integrity and leak, putting patients at serious risk of embolism and infection.
To date, the company has reported 10 serious patient injuries linked to the catheters. As a result, BD sent a letter to known customers, recommending that many of the devices be quarantined and removed from supply before being used on patients.
What is being recalled?
BD and the FDA are recalling the following PowerPICC Intravascular Catheters.
- 4 Fr. Single Lumen PowerPICC
- SOLO and non-SOLO versions
The full list of affected devices including identifying numbers can be found here. They are to be removed from where they are sold and should not be used on patients.
Next Steps
On March 11, 2025, BD sent all affected health care providers an Urgent Medical Device Product Recall notice. Per the alert, all hospitals, clinics and suppliers should search inventory for the affected products above and destroy all unused products. However, if one of the recalled catheters is currently being used on a patient, monitor them closely for any negative symptoms—such as pain or swelling—and examine the device for any sign of wear or damage.
To reduce the likelihood of material fatigue for in-use catheters, BD recommends the following:
- Use adhesive-backed securement systems instead of compression-style securement systems.
- Use an appropriately sized securement system to accommodate the increase in diameter of the catheter in the taper region.
- Fully insert the PICC as close as possible to the zero-centimeter mark. This allows the kink-resistant, tapered region to be utilized and is associated with lower catheter leakage rates. See image below.
BD and FDA said providers should stop any infusion if any risk is noticed. Otherwise, clinicians should weigh risk and benefits based on the patient’s infusion needs. No further action is required if all is deemed to be safe.
The full FDA alert can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.