The Recall Desk
SevereFDA (Devices)·Z-2390-2023·Announced 2023-08-23

Dialysis Catheter Occlusion Recall Due to Excessive Lubricant Coating

Covidien recalls 647 MAHURKAR dialysis catheters due to center lumen occlusion caused by excessive silicone lubricant. The blockage may delay treatment or increase risks of blood clots.

What this means for you

Illness, injury, or structural failure has been reported. 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, which establishes a minimum severity floor of Severe per classification rules. Although no deaths or serious injuries have been reported, the concrete defect in a critical dialysis catheter poses significant risk of treatment delay and serious complications including thrombosis, embolism, and hemolysis.

Plain-English summary

Covidien LP is recalling 647 units of the MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter (24 cm, Curved Extensions Kit, REF 8888345637) due to occlusion in the center lumen of the catheter tip. The occlusion is caused by excessive application of MDX, a silicone-based lubricant used to coat the catheter during manufacturing. The affected lot numbers are 2124600191 and 2127300121.

When the center lumen becomes partially or fully occluded, the catheter may not function properly. A full obstruction blocks blood flow and prevents dialysis from proceeding, causing treatment delays. A partial obstruction reduces the flow rate. Additionally, if particles of the lubricant dislodge from the catheter tip, they may enter the patient's bloodstream, potentially causing hemolysis (destruction of red blood cells), embolism (blockage of blood vessels by foreign material), or thrombosis (formation of blood clots).

The affected catheters were distributed in the United States and internationally to Argentina, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Cayman Islands, China, Costa Rica, Czech Republic, Denmark, Dominican Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Malaysia, Maldives, Mauritius, Mexico, Nepal, Netherlands, New Caledonia, Nicaragua, Norway, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom.

If you have these catheters, stop using them immediately and contact Covidien for replacement. If you have used an affected catheter and experience symptoms such as treatment delays, reduced blood flow, or signs of blood clots, contact your healthcare provider immediately.

The recalled product

Product
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Manufacturer
Covidien LP
Category
Medical Device — Dialysis / Vascular Access
Hazard
  • catheter-obstruction
  • thrombosis
  • embolism
  • hemolysis

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: 10884521006829/ 20884521006826 LOT Numbers: 2124600191 2127300121

Distribution

Distributed nationwide across the United States.

Related recalls

Same category