Dialysis Catheter Recalled Due to Excessive Lubricant Causing Center Lumen Obstruction
Covidien is recalling MAHURKAR dialysis catheters due to excessive silicone-based lubricant coating the center lumen tip, which may cause partial or complete obstruction, delaying treatment or causing thrombosis.
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: FDA Class I classification requires a minimum severity score of 4. While no deaths or actual reported injuries are documented, the device defect poses significant risk of serious complications including thrombosis, embolism, and hemolysis, combined with potential for treatment delay in dialysis patients.
Plain-English summary
The MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, manufactured by Covidien LP, is being recalled. The product is a sterile, single-use dialysis catheter with a 16 cm curved extension. Approximately 6,615 units are affected, distributed nationwide and internationally.
The center lumen of the affected catheters contains an occlusion in the tip caused by excessive MDX, a silicone-based lubricant. Uncured or excessive MDX may dislodge from the catheter, leading to partial or full blockage of the center lumen.
A fully occluded center lumen would result in complete catheter obstruction, preventing or significantly delaying dialysis treatment. A partially occluded lumen would reduce blood flow during treatment. Dislodged lubricant particles may cause hemolysis (breakdown of red blood cells), embolism (particle-induced blockage), or thrombosis (blood clot formation), all of which could delay necessary treatment.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- hemolysis
- embolism
- thrombosis
Distribution
Distributed nationwide across the United States.
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