The FDA this week said the Medtronic (NYSE:MDT) recall of some Mahurkar hemodialysis catheters is Class I, the most serious kind.

Medtronic is recalling its Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters, also known as Mahurkar QPlus, due to reports of a potential catheter hub defect that could cause leaks in a catheter’s tubes.

According to the company, the leak could result in arterial and venous blood mixing during treatment and lead to increased recirculation and poor dialysis. The defect could also cause the development of blood clots in the blood vessels. Continued use of the catheters could result in serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter.

There are 22,763 devices involved in the recall, with distribution dates of March 19, 2022, to September 2, 2022.

So far, two reports of injuries related to this issue have been reported. No deaths have been reported.

Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters are implanted and used in hemodialysis, aphaeresis and infusion for up to 21 days.

Medtronic set up a website for users to determine if a product is affected by the recall. Note: The affected devices are within a kit, IC tray or PASS tray. Visit the website tool here.

Recommendations from the company

Medtronic said that patients who are receiving care using the Mahurkar catheter and healthcare professionals providing care using the catheter might be affected by the recall.

For devices currently in use, the company recommends clinicians look for visible communication or movement of catheter contents between venous and arterial lumens within the catheter. It will not present as an external leak or defect. Medtronic is also recommending that if the issue is detected, the patient’s medical team should use clinical judgment in determining the necessity and timing of a replacement catheter according to the product’s instructions for use and facility-specific policies and procedures.

For all devices, Medtronic said healthcare providers should immediately quarantine and discontinue the use of all unused Mahurkar acute dual lumen high flow 13.5 Fr hemodialysis catheters from affected lots. The company also sent customer confirmation forms to complete with further instructions.

This is Medtronic’s second recall of the Mahurkar hemodialysis catheters. In July 2022, the company’s subsidiary Covidien recalled more than 1 million Palindrome and Mahurkar hemodialysis catheters due to a catheter hub defect that connected both extension catheters. That defect could cause a leak within the hub of a chronic dialysis catheter and also lead to arterial and venous blood mixing.