Agency classClass IOur severity:Critical FDA (Devices)·Z-2383-2023·Announced 2023-08-23

FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk

Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, which mandates a Critical (5) severity score per the rubric. FDA Class I recalls involve serious risk of adverse health outcomes including treatment delays, blood clots, thrombosis, and hemolysis in this critical-care dialysis application.

Plain-English summary

Covidien LP is recalling the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (Reference 8888345520HP, lot numbers 2018800011 and 2203900129). A total of 295 units were distributed worldwide.

The center lumen of affected catheters may contain an occlusion at the catheter tip caused by excessive MDX, a silicone-based lubricant. This occlusion, or partial occlusion, can result in complete catheter obstruction or significantly reduced blood flow during dialysis.

Patients using affected catheters risk treatment delays due to catheter obstruction or reduced flow. Additionally, if particulate material dislodges from the catheter, it may cause hemolysis (red blood cell destruction), embolism (blood clots), thrombosis (blood clot formation), or other serious complications.

Healthcare providers should verify that their inventory does not contain units from affected lot numbers 2018800011 and 2203900129. The FDA recalls database and Covidien LP provide additional information regarding this recall.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: occlusion
hemolysis
embolism
thrombosis
Affected units: 295

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: 20884521128115 LOT Numbers: 2018800011 2203900129

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 · occlusion