The U.S. Food & Drug Administration (FDA) is aware that BD and its subsidiary Bard Access Systems have issued a letter to affected customers recommending certain unused PowerPICC Intravascular Catheters be removed from where they are used or sold. Additionally, in-use PowerPICC Intravascular Catheters have updated instructions for use: 4 Fr. Single Lumen PowerPICC and SOLO and non-SOLO versions.
What You Need To Do
On March 11, 2025, BD sent all affected health care providers an Urgent Medical Device Product Recall notice recommending the following actions:
- Search your inventory for the affected product listed above and destroy all unused product.
- If the affected product is currently in use with a resident, BD is not recommending the device be explanted unless damage is suspected. Consider the resident's infusion needs, alternative access options, and the risks and benefits of continued catheter usage. Residents and clinicians should observe PICCs for any signs or symptoms that may be consistent with catheter fracture. These signs and symptoms include pain upon infusion, swelling of the arm not related to DVT, inability to withdraw blood, and leakage of fluids around the insertion site.
If catheter damage is suspected:
- Immediately stop any infusion.
- Follow your institution’s guidelines and check for damage including catheter fracture.
- If the catheter is confirmed to be fractured, the catheter should be removed and an alternative route for intravascular access should be obtained.
- To reduce the likelihood of material fatigue leak for in-use catheters, BD recommends the following:
- Use adhesive-backed securement systems (e.g. Statlock, Griplock, Tegadern, steri-strips) 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.
- For those who perform catheter insertion, 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.
- If affected product has already been used without incident, no further action is necessary.
The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. Customers in the United States with adverse reactions, quality problems, or questions about this issue should contact BD via the North American Regional Complaint Center at
productcomplaints@bd.com or 844-823-5433.