FDA Provides Update on Covidien’s Recall of Its Palindrome and Mahurkar Hemodialysis Catheters

The FDA has issued an update on Covidien’s June 8 recall of its Palindrome and Mahurkar hemodialysis catheters, deeming it a Class 1 recall because of the risk of serious injury or death.

The recall by the Medtronic subsidiary was prompted by a potential defect in the connection with extension catheters. Specifically, there is a risk of a leak of fluid through the tip of one extension catheter with unanticipated fluid flowing into the adjacent extension tube.

Such a leak could result in mixing of the arterial and venous blood and lead to increased recirculation and poor dialysis, as well as blood clots, the agency said.

The recall affected more than a million products distributed from June 28, 2017 to May 11, 2022.

There has been one complaint but no injuries or deaths linked to the defect so far, the FDA said.