Agency classClass IOur severity:Severe FDA (Devices)·Z-2382-2023·Announced 2023-08-23

Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall

Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular 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: This is an FDA Class I recall, which by regulation indicates a serious safety hazard. The occlusion can result in treatment delays and serious complications including hemolysis, embolism, and thrombosis, though no illnesses or deaths have been reported.

Plain-English summary

Covidien LP has issued a Class I recall of the Mahurkar 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (16 cm, curved extensions, REF: 8888345512HP). The recall affects 600 units distributed nationwide in the United States and in multiple countries worldwide.

The recall is due to excessive MDX, a silicone-based lubricant, coating the catheter tip's center lumen. This excessive or uncured lubricant coating can cause a full or partial occlusion of the catheter center lumen or may dislodge from the catheter tip.

An occluded catheter can result in full catheter obstruction, causing delay to treatment, or partial obstruction, resulting in reduced flow. Dislodged particulate matter may also cause delay to treatment, hemolysis, embolism, or thrombosis.

Affected lot numbers are: 2018800014, 2023400145, 2027200276, 2119400215, 2130800064, and 2201000047. Healthcare providers and patients should contact Covidien LP and consult the FDA for guidance on device inspection, patient assessment, and return procedures.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Manufacturer: Covidien LP
Category: Medical Device — Acute Dialysis Catheters
Hazard: catheter-occlusion
hemolysis
embolism
thrombosis
Affected units: 600

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 occlusion