Agency classClass IOur severity:Severe FDA (Devices)·Z-2369-2023·Announced 2023-08-23

Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

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 minimum severity level 4 (Severe). The defect can cause complete catheter obstruction with potential for serious complications including embolism and thrombosis.

Plain-English summary

Covidien LP is recalling 5,373 units of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (REF: 8888101003HP). The affected units were distributed nationally in the United States and internationally in multiple countries. The lot numbers affected are 2130900104, 2133600083, 2133600160, 2133600165, 2226500171, 2226500173, 2227800101, 2227800104, 2227800109, and 2230400208.

The FDA classified this as a Class I recall because examination of the affected catheters revealed occlusions in the center lumen tip caused by excessive amounts of MDX, a silicone-based lubricant coating. The excessive, uncured, or partially cured lubricant may dislodge from the catheter tip.

Full or partial dislodgement of the MDX can result in complete or partial obstruction of the catheter lumen. Complete obstruction can cause delay to patient treatment. Partial obstruction can reduce flow rates. Dislodged lubricant particles may lead to hemolysis (damage to red blood cells), embolism (blood clots in blood vessels), or thrombosis (formation of blood clots).

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: catheter-obstruction
treatment-delay
hemolysis
embolism
thrombosis
Affected units: 5,373

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 →

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Same hazard · catheter obstruction