Navilyst—Power Injectable PICC Catheters Contained in BioFlo PICC with Endexo and PASV and Xcela PICC with PASV Valve Technology Kits: May Have Increased Incidence of Hemolyzed Blood Samples

ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a December 31, 2014, Urgent Voluntary Medical Device Recall letter submitted by ECRI Institute member hospitals, Navilyst states that the catheters below may have an increased incidence of hemolyzed blood samples, which may require additional peripheral access or replacement of the PICC catheter. Navilyst states that the catheters below contain valves that were manufactured before October 9, 2013, and that valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. Navilyst also states that it has received no reports of patient injury related to this problem. The manufacturer has not confirmed the...