Medtronic recalls hemodialysis catheters; reports occlusion issue
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Key takeaways:
- Medtronic issues recalls for two types of hemodialysis catheters.
- Testing revealed that excessive lubricant on the catheter tips could result in occlusion and cause dislodgement of the catheter.
Medtronic has issued a voluntary recall on two types of hemodialysis catheters after tests revealed excessive amounts of a lubricant on the tip could block flow or dislodge the catheter, according to a company letter to customers.
The Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters from the company have been designated as a class I recall, which is “the most serious type of recall,” according to a recall notice issued by the FDA. “Use of these devices may cause serious injuries or death.”
Medtronic is offering a tool to identify affected units and requests that the devices be quarantined and returned immediately, according to the letter.
The company said that during manufacturing-related testing, the tip of the catheter’s center lumen occluded after MDX, a silicone-based lubricant that is provided with the catheter, was excessively applied to the tip of the catheter.
“An incorrect application of MDX to catheters may result in the hazardous situation whereby the catheter is occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter,” according to the Medtronic letter. “An occurrence of the hazardous situation may lead to potential harms identified as full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus.”
Medtronic said the recall affects manufacturing lots with numbers 18282 through 23016; the FDA estimates that includes 210,200 catheters, according to the lots listed in the recall notice.
In November 2022, Medtronic recalled its Mahurkar Acute Lumen High Flow Catheters for a catheter hub defect that could cause the catheter tubes to leak. That recall was also designated as a class I recall by the FDA.
References:
Urgent: Medical device recall. https://www.medtronic.com/covidien/en-us/products/c/mahurkar---acute-triple-lumen-catheter-recall-tool.html. Published June 2023. Accessed Aug. 22, 2023.
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