With 210K dialysis catheters being recalled due to potential blockages, Medtronic is under fire once more

Medtronic, a medical technology company, faced scrutiny from the FDA as its dialysis catheters face recall. These catheters have been identified as having the possibility of becoming obstructed due to the accumulation of silicone-based lubricant. As a response to this issue, the FDA has issued another Class I tag, indicating the most severe level of recall.

Previously, the company had encountered two instances resulting in Class I categorization, the most severe level, for the recall of medical devices. These recalls concerned a total of 1 million hemodialysis catheters in the first case and an additional 359,000 in the subsequent instance. The common problem across these recalls was the potential risk of internal leaks and cross-contamination associated with the catheters.

However, FDA’s attention has once again turned towards Medtronic’s dialysis catheters, this time due to a completely different issue. The current recall encompasses roughly twenty-four models of Mahurkar acute triple lumen and acute high-pressure triple lumen catheters. These models are listed in the FDA’s recall database, and the dialysis catheters recall affects more than 210,200 catheters that have been distributed globally.

Types of dialysis catheters: 

Unlike standard catheters used in dialysis, which usually have two tubes for drawing blood from the body and returning it post-dialysis, the catheters in question have a third lumen. This extra pathway is designed to remain accessible for blood access, fluid infusion, or medication delivery between dialysis sessions.

In a communication directed towards healthcare providers in June, Seth Kersten, a senior director at Medtronic’s renal care solutions division, explained that certain catheter center lumens were found to be blocked at their tips. A thorough investigation revealed that these blockages were attributed to the incorrect application of “excessive MDX,” a lubricant utilized for smoother catheter insertion and removal. The blockage, if complete, could lead to delays in essential patient treatment. Even a partial blockage could hinder the flow of the dialysis process. Worse still, if the excess lubricant dislodges from the catheter into the patient’s body, it could trigger complications such as hemolysis (the destruction of red blood cells), embolisms (obstructions in blood vessels), or thrombosis (clot formation).

Notably, as of early June, when the recall was officially initiated, no confirmed complaints regarding the blockage risk had been received by the company. Healthcare providers can utilize Medtronic’s online tool to determine if the catheters they possess are subject to recall.

Medtronic has advised that healthcare providers replace any of the affected catheters, which are designed for usage over a span of up to 29 days. However, the decision on when to replace the catheters should be made in consultation with the patient’s medical team to assess overall patient risk. Unused catheters impacted by the recall should be promptly quarantined and returned to Medtronic for appropriate handling.

Seth Kersten expressed regret for any inconvenience caused and reaffirmed Medtronic’s dedication to patient safety, while also acknowledging and appreciating the immediate attention given to the matter.