Mahurkar 12 Fr (hemodialysis catheters)

2023: Product Recall

On August 11, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of defective hemodialysis catheters manufactured by Medtronic. The use of defective products can provoke thrombosis.

The recall includes Mahurkar 12 Fr 20 cm long three-lumen high-pressure acute dialysis catheters with curved extensions. Such products contain an additional third lumen, which allows monitoring of central venous pressure, infusion and administration of contrast preparations under high pressure, infusion therapy and transfusion.

Mahurkar 12 Fr catheter

In defective products, the central lumen has occlusion at the tip of the catheter, the FDA official notice said. The reason is the excessive amount of silicone-based lubricant that covers the tip of the catheter. In certain situations, this can lead to complete obstruction of the catheter, which will affect the therapy. Among the negative effects are treatment delay, hemolysis, embolism and thrombosis. As a result, significant harm to the health of the patient can be caused.

In total more than 15 thousand rejected catheters of Mahurkar 12 Fr with the following lot numbers are subject to a response: 1828200086, 1925300170, 1925300171, 2018800013, 2018800024, 2018800043, 2019500199, 2019500200, 20195. 00222, 2021000106, 2021000107, 2029600102, 2029600103, 2116600083, 2131200176, 2133700166, 2227800108, 2230400250, 2230400251, 2234800071. It is noted that such products were supplied to many countries around the world. Medtronic emphasizes that the problem does not affect catheters of the Mahurkar Elite family. Whether cases of harm to the health of patients are recorded is not reported.^[1]

Notes