Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 15,209

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

Same manufacturer · Covidien LP

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Same hazard · catheter occlusion