Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology Recalled by Navilyst Medical, Inc., an AngioDyamics Company Due to PICC catheters that contain valve(s) manufactured prior to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Navilyst Medical, Inc., an AngioDyamics Company directly.
Affected Products
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Quantity: 275 units
Why Was This Recalled?
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Navilyst Medical, Inc., an AngioDyamics Company
Navilyst Medical, Inc., an AngioDyamics Company has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report