Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters are implanted and used in hemodialysis (treatment to filter waste and water from the blood), apheresis (a technology that separates donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream) for up to 21 days.
Medtronic is recalling the Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters due to a potential catheter hub defect that may cause leaks across the catheter’s tubes. During treatment, this leak could result in mixing of the arterial and venous blood, lead to increased recirculation and poor dialysis, or cause the development of blood clots in the blood vessels.
The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter.
There have been two injuries reported related to this issue and no reports of death.