Agency classClass IOur severity:Severe FDA (Devices)·Z-2375-2023·Announced 2023-08-23

Dialysis catheter recalled due to excessive lubricant causing obstruction

Covidien's MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can block the center lumen, preventing or reducing blood flow during dialysis. This Class I recall affects 271 units and carries risk of treatment delays, 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 classification applies because the obstruction can prevent or delay blood flow during life-sustaining dialysis treatment, with potential for serious complications including embolism, thrombosis, and hemolysis.

Plain-English summary

Covidien LP is recalling the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (reference number 8888103004HP, lot 2133700227). The recall involves 271 units distributed nationwide and internationally.

The catheters contain excessive MDX, a silicone-based lubricant used to coat the catheter tip. This excessive coating causes occlusion in the center lumen. Additionally, if the lubricant is not fully cured, particles can separate from the catheter.

The affected catheters provide vascular access for acute dialysis treatment. An occluded or partially occluded center lumen prevents or reduces blood flow during dialysis, which can delay treatment. Separated lubricant particles may cause additional complications. Healthcare facilities should immediately stop using affected catheters and contact Covidien for further instructions. Patients who received dialysis using potentially affected catheters should contact their healthcare provider.

A fully blocked catheter prevents necessary treatment. Potential complications include hemolysis (red blood cell destruction), embolism (blood clot or particle blockage), and thrombosis (blood clot formation).

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: catheter-obstruction
embolism
thrombosis
hemolysis
Affected units: 271

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:20884521128047 LOT Numbers: 2133700227

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