A catheter produced by Medtronic and used in haemodialysis has been recalled due to a defect that “may cause serious adverse health outcomes”. An update on the US Food and Drug Administration (FDA) website has laid out the specifics behind the recall as well as the organisation’s advice on how to proceed for those affected.
The update describes a catheter hub defect in the Mahurkar acute dual lumen high-flow (13.5 French) haemodialysis catheter, which is also used for apheresis and infusion. It states that this may lead to “leaks across the catheters tubes”, which in the course of treatment could cause the mixing of arterial and venous blood, as well as “increased recirculation and poor dialysis” and even the development of clots in blood vessels. These complications could lead to the need for surgical removal of the catheter or bleeding. Medtronic advises that use of a faulty device could lead to “inadequate treatment, unintended radiation exposure, haemolysis, thrombus formation, embolism, delay to treatment, and potential infection”.
So far, there have been two reports of injuries related to the issue, though no reports of death. The release states that those receiving or administering care with the catheter may be affected, before it proceeds to cite a 7 December, 2022 letter from Medtronic for recommendations. For those with a device already in use, it says, clinicians should follow routine assessment procedures for “patency, function and efficacy” of the device, while also monitoring for movement of the catheter’s contents between its venous and arterial lumens. “It will not,” they stress, “present as an external leak or defect.” If the defect is detected, “clinical judgment” should be used to determine the “necessity and timing” of replacement.
Medtronic’s website features a tool for determining whether a lot of the device is affected. The company advises clinicians to “immediately quarantine and discontinue use” of those affected and return them through their customer service portal. Finally, they recommend sharing the notice with “nephrologists, physicians, renal nurses, other dialysis or clinical staff who need to be aware”.