This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that BD and their 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, and in-use PowerPICC Intravascular Catheters have updated instructions for use:
- 4 Fr. Single Lumen PowerPICC
- SOLO and non-SOLO versions
List of affected devices (XLSX 30.9KB)
What 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 affected product is currently in use with a patient, BD is not recommending the device be explanted unless damage is suspected. Consider the patient's infusion needs, alternative access options, and the risks and benefits of continued catheter usage. Patients and users 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 infusate 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
- Fully insert the PICC as close as possible to the zero-centimeter mark (position B in Figure 1 below). 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.
Figure 1: Image of PowerPICC Taper Region
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Check this web page for updates. 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.
Reason for Early Alert
BD has identified an increase in material fatigue leaks associated with the affected catheters mostly seen as a transverse/circumferential crack in the catheter body, see Figure 2 below. BD’s investigations suggest this results from an issue with the material resin use to manufacture the catheter tubing.
Figure 2: Example of transverse/circumferential crack in the catheter body
The risks associated with material fatigue leakage include infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
BD has reported 10 serious injuries associated with this issue.
Device Use
The PowerPICC catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring.
Contact Information
Customers in the U.S. 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.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
