Medtronic dialysis catheters in hot seat again, with 210K recalled over possible blockages

Between last summer and the start of this year, Medtronic racked up two Class I tags from the FDA for a pair of recalls that first concerned 1 million hemodialysis catheters and then another 359,000, all of which were found to be at risk of internal leaking and cross-contamination.

Now, Medtronic’s dialysis catheters are in the FDA’s crosshairs once again, albeit for an entirely new issue. This time around, the catheters have been found to potentially become blocked due to a buildup of silicone-based lubricant.

The FDA has handed down another of its highest-severity Class I tags to the recall. It spans around two dozen models of the Mahurkar acute triple lumen and acute high-pressure triple lumen catheters, according to their respective entries in the agency’s recall database.

In total, more than 210,200 of the catheters have been distributed around the world.

Catheters used in dialysis procedures typically feature two tubes—one to remove blood from the body and send it through the dialysis machine, and the other to return the newly cleaned blood back to the body—but the recalled catheters include a third lumen between the standard two. According to Medtronic, the additional pathway “keeps an independent port ready for blood access and fluid or medication delivery between dialysis treatments.”

In a letter sent to healthcare providers in June, Seth Kersten, senior director of global quality within Medtronic’s renal care solutions division, described how some of those center lumens have been found to have occlusions in the catheter tip. Upon further investigation, the company concluded that the buildups came from the incorrect application of “excessive MDX,” a lubricant applied to the catheters for smoother insertion and removal.

If too much MDX is applied to a catheter, resulting in a full blockage, it could delay a patient’s needed treatment, while a partial blockage could reduce the flow of the dialysis procedure, Kersten noted in the letter. Additionally, if the excess MDX dislodges from the catheter into the patient’s body, along with delaying treatments, it could cause hemolysis or the formation of embolisms or thrombosis.

As of early June, when the recall officially began, the company had yet to receive any confirmed complaints related to the blockage risk.

Healthcare providers can use the devicemaker’s online search tool to determine whether any of the catheters they have in stock are included in the recall.

Medtronic has recommended that any of the affected catheters—which are designed to be used for up to 29 days—that are currently in use be replaced, though Kersten added in the letter that “the patient’s medical team should assess the overall patient risk when considering the timing of a replacement.”

All unused catheters covered by the recall, meanwhile, should be immediately quarantined and returned to Medtronic for processing.

“We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter,” Kersten concluded in the letter.