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.
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. 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
- Hazard
- catheter-obstruction
- hemolysis
- embolism
- thrombosis
Distribution
Distributed nationwide across the United States.
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