Dialysis catheters recalled for potential center lumen obstruction
Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel 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: FDA classified this as a Class I medical device recall, which mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, the hazard involves potential obstruction of a life-sustaining dialysis catheter, risking treatment delay and serious cardiovascular complications.
Plain-English summary
Covidien LP is recalling the MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm with Curved Extensions (Reference 8888345603). The recall affects 45,880 units distributed in the United States and multiple countries worldwide.
The catheters were found to contain excessive MDX, a silicone-based lubricant, which accumulates on the catheter tip and creates an occlusion (blockage) in the center lumen. This blockage may be partial or complete. A fully obstructed catheter prevents or severely delays dialysis treatment; a partially obstructed catheter reduces blood flow. The accumulated lubricant may also dislodge as particles, potentially entering the bloodstream and causing hemolysis (destruction of red blood cells), embolism (blood vessel blockage), or thrombosis (blood clots).
This is a Class I recall by the FDA. The affected lot numbers are specified in the FDA's official notice. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
- Manufacturer
- Covidien LP
- Hazard
- catheter-obstruction
- treatment-delay
- hemolysis
- embolism
- thrombosis
- silicone-contamination
Distribution
Distributed nationwide across the United States.
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