Medtronic is recalling more than 22,000 hemodialysis catheters due to a possible defect in the device’s hub that could result in leakages and the mixing of arterial and venous blood, increasing recirculation or causing blood clots to form, the Food and Drug Administration said Monday.
Use of the defective implanted catheters may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter, the agency said. Two injuries related to the issue have been reported, and the FDA identified the recall as Class I, its most serious category.
The Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters were distributed from March 19 to Sept. 2, 2022. Medtronic initiated the recall of 22,763 devices on Nov. 23, and sent an Urgent Medical Device Recall letter on Dec. 7, advising clinicians to look for visible movement of catheter contents, the FDA said. If the issue is detected, the patient’s medical team should use their clinical judgment to determine whether a replacement catheter is needed, the agency said.
The implanted catheters are used to filter waste and water from the blood, separate donated blood components for certain illnesses, and for infusion, and can be used for up to 21 days.
The recall comes five months after the FDA announced a recall of more than 1 million Medtronic Palindrome and Mahurkar hemodialysis catheters for a hub defect, after a complaint was received. Medtronic has said it plans to divest its dialysis business into a new firm with DaVita.
The medtech giant is also facing a warning letter related to its handling of a recall of the MiniMed 600 series insulin pumps.