The Recall Desk
SevereFDA (Devices)·Z-2373-2023·Announced 2023-08-23

Dialysis Catheter Recall Due to Potential Lumen Occlusion

Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.

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 requires a minimum severity score of 4. The defect—lumen occlusion from excessive silicone lubricant—can result in treatment delays and serious vascular complications including thrombosis and embolism in patients dependent on dialysis.

Plain-English summary

Covidien LP is recalling the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (REF 8888103001HP) due to a manufacturing defect. The center lumen of affected catheters may become occluded due to excessive amounts of MDX, a silicone-based lubricant applied to the catheter tip.

Approximately 299 units with lot number 2133700228 have been distributed. The catheters were distributed nationwide in the US and to multiple countries worldwide, including Argentina, Austria, Canada, China, France, Germany, India, Mexico, the Netherlands, the Philippines, the United Kingdom, and others.

An occluded or partially occluded lumen may cause material to dislodge or prevent normal catheter function, resulting in delayed or interrupted treatment, reduced blood flow, hemolysis, blood clots (thrombosis), or arterial or venous blockages (embolism). Healthcare providers and patients should be aware of these risks and monitor for signs of catheter malfunction during dialysis treatment.

The recalled product

Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Manufacturer
Covidien LP
Category
Medical Device — Dialysis / Vascular Access
Hazard
  • occlusion
  • silicone-lubricant-contamination
  • embolism
  • thrombosis
  • particulate-shedding

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: 0884521128010 LOT Numbers: 2133700228

Distribution

Distributed nationwide across the United States.

Related recalls

Same category