Agency classClass IOur severity:Severe FDA (Devices)·Z-2381-2023·Announced 2023-08-23

MAHURKAR Dialysis Catheter Recalled for Excessive Lubricant Causing Occlusion

The MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can obstruct the center lumen, potentially delaying critical dialysis treatment.

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 recall. The defect risks treatment delay and serious complications (thrombosis, embolism, hemolysis) in dialysis patients. Although no injuries have been reported, FDA Class I classification mandates a minimum score of 4 (Severe) per the severity rubric.

Plain-English summary

The MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit (REF: 8888340637HP), manufactured by Covidien LP, is being recalled. Approximately 2,425 units have been distributed nationwide and internationally.

The defect involves the catheter's center lumen. An excessive amount of MDX, a silicone-based lubricant that coats the catheter tip, can cause the lumen to become occluded (blocked). The catheter may become partially or fully occluded, or uncured or excessive MDX may dislodge from the device. When this occurs, the result may be full catheter obstruction, delaying patient treatment, or partial obstruction that reduces blood flow through the catheter. Additionally, dislodged lubricant particles may lead to hemolysis (destruction of red blood cells), embolism (blood clot), or thrombosis (clot formation).

The affected lot numbers are: 1907700088, 2015100039, 2019500217, 2107700128, and 2113300287. The affected GTINs are: 10884521128088 and 20884521128085. The device has been distributed to facilities in the United States and numerous countries including Argentina, Brazil, Canada, China, France, Germany, India, Italy, Mexico, Netherlands, Philippines, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, and the United Kingdom.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis / Catheter
Hazard: catheter-occlusion
treatment-delay
hemolysis
embolism
thrombosis
Affected units: 2,425

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: 10884521128088

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 occlusion