Agency classClass IOur severity:Severe FDA (Devices)·Z-2385-2023·Announced 2023-08-23

Acute Dialysis Catheter Recalled for Potential Lumen Obstruction and Embolism Risk

Covidien is recalling MAHURKAR acute dialysis catheters for excessive silicone lubricant causing lumen obstruction that may delay treatment and lead to hemolysis, embolism, or thrombosis.

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 medical device recall. The rubric requires that FDA Class I recalls never score below 4. Although potential complications are serious (obstruction, embolism, thrombosis), no deaths or reported injuries have been documented.

Plain-English summary

Covidien LP is recalling the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (REF 8888345603HP) in affected lot numbers 2017400081, 2028300087, 2113300282, 2133700046, and 2227800105. Approximately 2,685 units were distributed nationwide in the United States and internationally.

The FDA has classified this as a Class I recall. The center lumen of affected catheters contains a defect: excessive MDX, a silicone-based lubricant that coats the catheter tip, which can cause the lumen to become partially or completely occluded. The lubricant may be uncured or may dislodge from the catheter.

Complete obstruction of the lumen would prevent catheter use, resulting in delayed treatment for patients requiring acute dialysis. Partial obstruction would reduce blood flow. If MDX lubricant particles dislodge into the patient's bloodstream, they could cause hemolysis (destruction of red blood cells), embolism (formation of blood clots), or thrombosis (blood clot formation).

Patients requiring acute dialysis treatment and healthcare facilities providing acute hemodialysis are affected by this recall. The obstruction and particulate hazards present serious health risks to patients whose treatment depends on proper catheter function.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
Manufacturer: Covidien LP
Category: Medical Device — Acute Dialysis Catheter
Hazard: catheter-obstruction
hemolysis
embolism
thrombosis
Affected units: 2,685

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 obstruction