FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk
Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.
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 of 4. The defect—excessive lubricant causing catheter obstruction—poses serious risk of treatment delay and life-threatening complications including thrombosis and hemolysis. No reported illnesses or deaths are documented in the source.
Plain-English summary
Covidien LP is recalling MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheters (24 cm with straight extensions), approximately 685 units with lot number 2200400154.
The catheters contain excessive MDX, a silicone-based lubricant coating on the catheter tip. This coating can partially or fully occlude the center lumen, blocking fluid flow.
An occluded catheter may delay patient treatment or result in reduced blood flow. Dislodged lubricant particles may cause hemolysis, embolism, or thrombosis. The affected catheters were distributed nationwide in the US and internationally.
Healthcare providers using these catheters should discontinue use and contact Covidien LP. Patients should consult their healthcare provider if they have received treatment with these catheters.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- thrombosis
- hemolysis
- embolism
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: 20884521128009 LOT Numbers: 2200400154
Distribution
Distributed nationwide across the United States.
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