Agency classClass IOur severity:Severe FDA (Devices)·Z-2388-2023·Announced 2023-08-23

Dialysis Catheter Recall Due to Center Lumen Occlusion

Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.

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 with no reported illnesses or injuries. The rubric mandates that FDA Class I recalls score no lower than 4 (Severe). The hazard is confirmed—excessive lubricant occlusion has been identified in the product—and poses serious risks including treatment delay and potentially life-threatening bloodstream complications for dialysis patients.

Plain-English summary

Covidien LP is recalling MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters, 20 cm with curved extensions (REF: 8888345629). The recall involves 6,949 units that were distributed nationally in the United States and to multiple countries worldwide.

The center lumen of the catheter was found to contain an occlusion at the catheter tip caused by excessive MDX, a silicone-based lubricant that coats the catheter. This excessive lubricant may not cure properly and could dislodge from the catheter, leading to full or partial catheter obstruction.

A fully or partially occluded catheter may delay dialysis treatment. Partial obstructions can reduce blood flow through the catheter. Dislodged lubricant particles may cause hemolysis (destruction of red blood cells), embolism (blood clots or particles traveling in the bloodstream), or thrombosis (blood clot formation), which are serious complications during dialysis treatment.

Affected lot numbers include: 2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, and 2127300113.

The recalled product

Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: occlusion
hemolysis
embolism
thrombosis
Affected units: 6,949

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

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · occlusion