FDA Issues Alert on Intravascular Catheters (SNF)

The Food and Drug Administration (FDA) is alerting health care professionals to a high-risk issue involving certain PowerPICC Intravascular Catheters, manufactured by BD and its subsidiary Bard Access Systems. The resin material in some of the devices can cause them to lose structural integrity and leak, putting residents at risk of embolism and infection. BD sent a letter to known customers, recommending that the devices be quarantined and removed from supply before being used.

Specifically, BD and the FDA are recalling the following PowerPICC Intravascular Catheters: 4 Fr. Single Lumen PowerPICC, SOLO and non-SOLO versions. Here is a full list of affected devices that should not be used. For detailed action steps, see the Urgent Medical Device Product Recall notice. In addition, the FDA is continuing to review this issue and will provide new information as it becomes available. Visit the FDA Medical Device Recall webpage to stay up to date.