Medtronic’s subsidiary Covidien issued a Class I recall of more than 1 million Palindrome and Mahurkar hemodialysis catheters.
Covidien issued the recall due to a catheter hub defect that will connect both extension catheters. The defect could leak within the hub of a chronic dialysis catheter, which can lead to mixing of the arterial and venous blood and lead to increased recirculation and poor dialysis and development of the thrombi and emboli.
Use of the recalled catheters may cause serious adverse health outcomes, including bleeding, surgical removal and replacement of the affected catheter, according to an FDA warning letter. There has been one complaint and no reports of death or injury related to the device.
Palindrome and Mahurkar catheters are implanted in patients and used in hemodialysis, aphaeresis and infusion.
The recall affects Palindrome and Mahurkar hemodialysis catheters manufactured between June 1, 2017 and April 1, 2022 with distribution dates of June 28, 2017 to May 11, 2022. There are 1,032,377 devices affected by the recall in the U.S. Specific lots involved in the recall can be found on the FDA database.
Medtronic issued an urgent medical recall letter to customers affected by the recall to inform them of the product issue and its potential health risks. The company recommends immediately quarantining and discontinuing use for the specific lots of chronic hemodialysis catheters. It also recommends identifying the potential contamination of fluid while flushing one extension tube to assess for the unanticipated simultaneous fluctuation of fluid in the adjacent extension tube.