Agency classClass IOur severity:Severe FDA (Devices)·Z-2368-2023·Announced 2023-08-23

Dialysis Catheter Recalled Due to Excessive Lubricant Causing Center Lumen Obstruction

Covidien is recalling MAHURKAR dialysis catheters due to excessive silicone-based lubricant coating the center lumen tip, which may cause partial or complete obstruction, delaying treatment or causing thrombosis.

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 score of 4. While no deaths or actual reported injuries are documented, the device defect poses significant risk of serious complications including thrombosis, embolism, and hemolysis, combined with potential for treatment delay in dialysis patients.

Plain-English summary

The MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, manufactured by Covidien LP, is being recalled. The product is a sterile, single-use dialysis catheter with a 16 cm curved extension. Approximately 6,615 units are affected, distributed nationwide and internationally.

The center lumen of the affected catheters contains an occlusion in the tip caused by excessive MDX, a silicone-based lubricant. Uncured or excessive MDX may dislodge from the catheter, leading to partial or full blockage of the center lumen.

A fully occluded center lumen would result in complete catheter obstruction, preventing or significantly delaying dialysis treatment. A partially occluded lumen would reduce blood flow during treatment. Dislodged lubricant particles may cause hemolysis (breakdown of red blood cells), embolism (particle-induced blockage), or thrombosis (blood clot formation), all of which could delay necessary treatment.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: catheter-obstruction
hemolysis
embolism
thrombosis
Affected units: 6,615

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