The Recall Desk
SevereFDA (Devices)·Z-2389-2023·Announced 2023-08-23

MAHURKAR Dialysis Catheter Recalled for Center Lumen Obstruction Risk

Covidien LP recalled 15,209 MAHURKAR dialysis catheters due to excessive lubricant in the center lumen, which may cause catheter occlusion, reduce blood flow, or lead to hemolysis and blood clots.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall: the manufacturing defect could cause serious injury through catheter obstruction leading to hemolysis, embolism, or thrombosis. No illnesses have been reported to date.

Plain-English summary

Covidien LP is recalling approximately 15,209 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (20 cm, curved extensions) due to a manufacturing defect. The recalled catheters are identified by specific lot numbers and were distributed worldwide.

The center lumen of affected catheters contains excessive MDX, a silicone-based lubricant applied to the catheter tip. This excessive or uncured lubricant can dislodge during use or harden during manufacturing, resulting in partial or complete blockage of the center lumen.

Affected catheters may cause delayed treatment due to reduced or blocked blood flow. Dislodged lubricant material or catheter obstruction may result in serious complications including hemolysis, embolism, and thrombosis.

The recalled product

Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
Manufacturer
Covidien LP
Category
Medical Device
Hazard
  • catheter-occlusion
  • hemolysis
  • embolism
  • thrombosis

Distribution

Distributed nationwide across the United States.

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