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(VASA recommendation)
 
In July 2022 Medtronic issued a Class 1 recall for its Palindrome Precision and Palindrome Crhonic Hemodialysis Catheters as well as the Mahurkar Chronic Carbothane Catheters (https://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub ).

The reason for the recall is a defect that may exist in the molded hub between the clear catheter extensions and the white catheter  which allows fluid to move between arterial and venous lumen of the catheter.
 
Affected catheters may be associated with:

  • thrombosis of a catheter lumen
  • possible embolization of thrombus material
  • decrease in clearance
  • hyperkalemia
  • ineffective delivery of medications intravenously administered during dialysis
  1.  
    The company identified that about 1.6% of molded hubs are affected by this defect. Hubs, extensions and catheters are manufactured independently from each other and then assembled. For this reason, lot number from 2017 until 2022 could be affected and catheter lot numbers do not allow identification if an affected hub.
     
    Medtronic advises that catheter can be identified observing the catheter during usual use:  “To identify the potential contamination of fluid, while flushing one extension tube, assess for the unanticipated simultaneous fluctuation of fluid in the adjacent extension tube.” (https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool )
     
    VASA advise that affected catheters are not reliable identified during routine use. Instead a dedicated testing procedure of potentially affected catheters should be performed. Click here to download a suggested protocol. Once affected catheters are identified, clinicians need to way the risks of a replacement procedure and continued use of a defective catheter.

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