FDA announces recall of hemodialysis catheters due to risk of leaks, adverse outcomes
The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling its Mahurkar Acute Dual Lumen High-Flow Hemodialysis Catheter, also known as the Mahurkar QPlus, due to a potential defect that can result in leaks.
These devices are designed to be used during hemodialysis, apheresis and infusion procedures. The recall covers 22,763 catheters distributed to customers from March 19, 2022, to Sept. 2, 2022. There have been seven complaints so far about this issue. Two adverse events related to the issue—insufficient flow in one patient and a blood clot in another—have been reported.
“The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter,” according to the FDA’s advisory.
Other possible outcomes, according to Medtronic, include inadequate therapies, radiation exposure, hemolysis, significant blood clots, delays in treatment and infection.
The Medtronic website includes a tool that allows users to determine in their possession is included in this recall. Any unused devices that are, in fact, part of the recall should be immediately quarantined and not used in patient care. They should then be returned to Medtronic.
If a device included in the recall is currently in use, clinicians should look for signs of “communication” between the contents of the catheter, which should be completely separated. It will not necessarily present as an external leak. If any potential leaks are detected, it is recommended that clinicians use “their clinical judgement” to determine if it is necessarily to replace the catheter.
“Share this notice with the organization’s nephrologists, physicians, renal nurses, other dialysis or clinical staff who need to be aware,” according to the FDA.
The full FDA advisory is available here. Additional details from Medtronic are available here.
Medtronic did emphasize that this recall does not include the company’s Mahurkar Elite High-Flow Catheters.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.