Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall
Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular 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: This is an FDA Class I recall, which by regulation indicates a serious safety hazard. The occlusion can result in treatment delays and serious complications including hemolysis, embolism, and thrombosis, though no illnesses or deaths have been reported.
Plain-English summary
Covidien LP has issued a Class I recall of the Mahurkar 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (16 cm, curved extensions, REF: 8888345512HP). The recall affects 600 units distributed nationwide in the United States and in multiple countries worldwide.
The recall is due to excessive MDX, a silicone-based lubricant, coating the catheter tip's center lumen. This excessive or uncured lubricant coating can cause a full or partial occlusion of the catheter center lumen or may dislodge from the catheter tip.
An occluded catheter can result in full catheter obstruction, causing delay to treatment, or partial obstruction, resulting in reduced flow. Dislodged particulate matter may also cause delay to treatment, hemolysis, embolism, or thrombosis.
Affected lot numbers are: 2018800014, 2023400145, 2027200276, 2119400215, 2130800064, and 2201000047. Healthcare providers and patients should contact Covidien LP and consult the FDA for guidance on device inspection, patient assessment, and return procedures.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
- Manufacturer
- Covidien LP
- Hazard
- catheter-occlusion
- hemolysis
- embolism
- thrombosis
Distribution
Distributed nationwide across the United States.
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