The FDA has issued an urgent recall for specific Bard PowerPICC Intravascular Catheters. Healthcare providers and regulatory teams are alerted to critical safety issues that may pose serious injury or fatal risks. This recall underscores the need for immediate action by affected facilities.
What changed?
On March 11, 2025, BD (Becton, Dickinson and Company) and its subsidiary Bard Access Systems released an Urgent Medical Device Product Recall notice. The recall involves both the removal of unused PowerPICC catheters and updated usage instructions for already-implanted devices. The FDA identified this recall as its highest risk category, emphasizing the potential for harm.
Why is this recall important?
BD has identified a troubling increase in material fatigue leakages in affected devices, which primarily manifest as transverse or circumferential cracks in the catheter body. Their investigation traced the issue to a specific resin material used in manufacturing the catheter tubing.
These cracks can lead to severe complications, including air embolism, foreign body embolism, extravasation, infection, discomfort, and possibly life-threatening therapy interruptions. Ten serious injuries have already been linked to these failures.
Which devices are affected?
Specific models under recall include:
- 4 Fr. Single Lumen PowerPICC
- SOLO and non-SOLO versions
A full list of affected devices can be reviewed in the BD-provided spreadsheet (XLSX, 27.9KB).
What actions should be taken?
Health care teams should immediately search their inventory for the identified devices and destroy unused products. For catheters currently implanted, BD advises against removal unless damage is suspected. Monitoring and evaluation are critical in these cases.
Key instructions provided by BD:
- If damage is suspected, stop any infusion immediately.
- Inspect for signs of catheter fracture based on institutional guidelines.
- If confirmed, remove the catheter and seek alternative access options.
To reduce potential risks with in-use catheters, adhere to the following guidelines:
- Use adhesive-backed securement systems to reduce tubing stress.
- Choose appropriately sized securement systems to avoid over-compression.
- Fully insert the catheter at the zero-centimeter mark to utilize the tapered region, which lowers the likelihood of leakage.
If the product has been used without issues, no additional action is necessary.
How to report problems
Adverse events, reactions, or questions related to these devices should be reported to BD via their complaint center at productcomplaints@bd.com or by phone at 844-823-5433.
The FDA encourages healthcare professionals and consumers to submit adverse event reports using the MedWatch system.
What is the intended use of PowerPICC catheters?
The PowerPICC catheter is designed for short or long-term peripheral access to the central venous system. It supports intravenous therapy, power injection of contrast media, and central venous pressure monitoring.
Why is UDI important?
The Unique Device Identifier (UDI) system plays a critical role in identifying medical devices quickly. It enhances reporting accuracy, improves adverse event analysis, and accelerates problem resolution. For assistance with identifying a UDI label, resources like the AccessGUDID database are available.
Conclusion
This recall demands attention from healthcare, quality, and regulatory teams to mitigate risks associated with Bard PowerPICC catheters. Ensuring compliance with BD’s recommendations is essential to maintaining patient safety and avoiding adverse outcomes.
Disclaimer
This information is provided for healthcare professionals and regulatory teams and does not constitute legal or medical advice. Always consult official guidance for compliance purposes.