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# Class 1 Recall of Medtronic ‘Leaky’ Catheters
- URL: https://www.fdaweb.com/class-1-recall-of-medtronic-leaky-catheters/
- Published: 2023-01-30T12:00:00.000Z
- Updated: 2026-09-14T18:13:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153651

FDA has classified as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the device hub. “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,” a recall notice says. (XXINSERT LINKXX) The catheters are implanted and used in hemodialysis, apheresis, and infusion for up to 21 days. To date, two injuries have been reported.