Agency classClass IOur severity:Severe FDA (Devices)·Z-2380-2023·Announced 2023-08-23

FDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk

Covidien's Mahurkar acute dialysis catheters may have excessive silicone lubricant causing tip obstruction. This could delay treatment or cause serious complications including blood clots and 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 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 recalls require a minimum severity score of 4. No deaths or injuries are currently reported, but Class I designation indicates serious potential for harm. The risk of catheter obstruction in dialysis patients could result in treatment delays and serious clinical complications including embolism, thrombosis, and hemolysis.

Plain-English summary

Covidien LP is recalling 775 units of the MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions (Reference 8888340637) across the United States and internationally. The recall affects three lot numbers: 2119400209, 2122900117, and 2124600187.

The catheter's center lumen was found to have occlusion at the tip caused by excessive MDX, a silicone-based lubricant applied during manufacturing. An occluded or partially occluded catheter may fail to function properly. Additionally, uncured or excessive lubricant may dislodge from the catheter tip.

Complete obstruction can delay dialysis treatment. Partial obstruction can reduce blood flow during treatment. Dislodged lubricant particles may cause hemolysis (destruction of red blood cells), embolism (blood vessel blockage), or thrombosis (blood clots). Patients and healthcare providers should inspect catheters before use and report any unusual signs to their healthcare provider. Those with affected lot numbers should contact Covidien or their healthcare facility for guidance.

The recalled product

Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Manufacturer: Covidien LP
Category: Medical Device — Hemodialysis Equipment
Hazard: catheter-obstruction
embolism
thrombosis
hemolysis
Affected units: 775

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: 20884521057026 LOT Numbers: 2119400209 2122900117 2124600187

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 obstruction