Agency classClass IOur severity:Severe FDA (Devices)·Z-2367-2023·Announced 2023-08-23

Covidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk

Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.

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: This is a Class I FDA medical device recall. While no illnesses or injuries have been reported, the product poses a serious risk of catheter obstruction, treatment delay, and life-threatening complications including hemolysis, embolism, and thrombosis in critically ill dialysis patients, meeting the threshold for a Severe recall.

Plain-English summary

Covidien LP is recalling 2,370 units of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (model 8888101001HP) in affected lot numbers 2133600127, 2133700049, and 2200400180.

The catheters' center lumens contain excessive and/or uncured silicone-based lubricant (MDX). This lubricant can occlude the catheter lumen partially or fully, or dislodge as particulates within the bloodstream.

A fully obstructed lumen would prevent blood flow and delay dialysis treatment. Partial obstruction would reduce blood flow. Dislodged lubricant particles may cause hemolysis (the breakdown of red blood cells), embolism, or thrombosis—serious complications in patients who depend on dialysis.

These catheters were distributed nationwide and internationally to healthcare facilities.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis / Vascular Access
Hazard: catheter-occlusion
treatment-delay
hemolysis
thromboembolism
Affected units: 2,370

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

GTIN:20884521127897 LOT Numbers: 2133600127 2133700049 2200400180

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