Agency classClass IOur severity:Severe FDA (Devices)·Z-2372-2023·Announced 2023-08-23

FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk

Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.

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 classification requires a minimum severity of 4. The defect—excessive lubricant causing catheter obstruction—poses serious risk of treatment delay and life-threatening complications including thrombosis and hemolysis. No reported illnesses or deaths are documented in the source.

Plain-English summary

Covidien LP is recalling MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (24 cm with straight extensions), approximately 685 units with lot number 2200400154.

The catheters contain excessive MDX, a silicone-based lubricant coating on the catheter tip. This coating can partially or fully occlude the center lumen, blocking fluid flow.

An occluded catheter may delay patient treatment or result in reduced blood flow. Dislodged lubricant particles may cause hemolysis, embolism, or thrombosis. The affected catheters were distributed nationwide in the US and internationally.

Healthcare providers using these catheters should discontinue use and contact Covidien LP. Patients should consult their healthcare provider if they have received treatment with these catheters.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Equipment
Hazard: catheter-obstruction
thrombosis
hemolysis
embolism
Affected units: 685

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: 20884521128009 LOT Numbers: 2200400154

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 obstruction