FDA Recalls Four Merit Medical Hemodialysis Catheters for Hemorrhage Risk

FDA issued four separate Class I recalls for Merit Medical hemodialysis catheters, including CentrosFLO, ProGuide, BioFlo, and DuraMax models. All recalls stem from an identical design defect in the 16F dual-valved splittable sheath introducer that may not split properly, potentially causing hemorrhage during insertion procedures.

The ProGuide recall involves 847 units, while the BioFlo recall and DuraMax recall affect additional product lines with the same defect. Class I is the most serious recall classification, reserved for situations where reasonable probability of serious adverse health consequences exists.

Healthcare facilities with these catheters in inventory should quarantine and return the products per Merit Medical's recall instructions.