Third Class I Recall Hits Medtronic Hemodialysis Catheters

Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class I by the FDA, because use of the device could cause serious injury or death.

The 15,209 triple-lumen catheters affected by the recall were found to have an occlusion in the tip of the central lumen resulting from an excessive amount of MDX, a silicone-based lubricant which coats the catheter tip. The substance may dislodge and reduce or block flow, resulting in delay to treatment, destruction of red blood cells, an embolism, or thrombosis.

This recall does not include Mahurkar Elite catheters.

Read the Medtronic recall letter here.

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