Dialysis Catheter Recalled for Center Lumen Occlusion Risk
Covidien LP is recalling 3,965 MAHURKAR dialysis catheters due to excessive lubricant causing center lumen occlusion. This may obstruct blood flow or cause hemolysis and 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: FDA Class I device recall for a critical care catheter with potential for serious vascular complications including hemolysis, embolism, and thrombosis. FDA Class I classification mandates a minimum Severe rating.
Plain-English summary
Covidien LP is recalling 3,965 units of MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (REF: 8888345637HP). The center lumen of affected units contains excessive MDX, a silicone-based lubricant, which can cause partial or full occlusion at the catheter tip.
Occlusion may result in full catheter obstruction, causing delayed treatment, or partial obstruction reducing blood flow during dialysis. If the excessive lubricant dislodges, it may cause particulate matter to enter the bloodstream, potentially resulting in hemolysis, embolism, or thrombosis.
The affected lot numbers are: 1916500156, 2017400085, 2028300088, 2102600094, 2104600149, 2107700145, 2113100057, 2119400230, 2123000100, 2133700164. Distribution includes the United States and multiple international locations.
Patients and healthcare providers should verify the lot number of any MAHURKAR catheters in use and immediately discontinue use of units from the affected lots. Contact Covidien LP for instructions on appropriate next steps.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- hemolysis
- embolism
- thrombosis
- particulate-dislodgement
Distribution
Distributed nationwide across the United States.
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