Medtronic lands FDA Class I tag as it adds 359K potentially leaky dialysis catheters to recall

Just a few months after it began a recall of more than 1 million hemodialysis catheters that were found to be at risk of leakages, Medtronic has spotted the same issue in yet another model of its catheters.

Now under a recall of their own are more than 359,700 of the Mahurkar acute dual-lumen high-flow catheters made by Medtronic subsidiary Covidien, according to an entry in the FDA’s recall database. Only about 23,000 of the catheters are currently in use in the U.S., while the other 336,000 have been distributed in several dozen countries around the globe—all during the six months between March and September of last year.

The prescription-only devices, commonly known as the Mahurkar QPlus catheters, are implanted under the skin for up to three weeks for a variety of uses: to filter the blood during dialysis, separate components of the blood for apheresis procedures and send needed fluids into the bloodstream in infusions.

In a letter sent to healthcare providers in December, Medtronic described its discovery that a “void” present in some of the catheters’ central hubs could cause internal leaking within a device during hemodialysis, potentially allowing cross-contamination between the catheter’s two lumens—one directing blood out of the body and the other bringing freshly filtered blood back in.

According to the company, the leakage could not only result in improper or delayed treatments but could also expose patients to unnecessary radiation, destroy red blood cells, create blockages in the blood vessels and spark infections.

As of mid-October, Medtronic said it has received seven complaints, though only one has been a confirmed case of “interlumen communication.” The complaints included two reports of injuries—one case of thrombosis and another of insufficient blood flow—and no patient deaths.

This week, the FDA gave the recall its most serious Class I designation, bestowed upon device issues that pose the highest risk of injury or death.

Medtronic is in the process of removing all affected catheters from hospital workflows. The company has asked all customers to compare the serial numbers of their Mahurkar QPlus catheters to those included in the recall and, if any are found, immediately quarantine and return them to Medtronic.

If any of the catheters are currently in use, however, they may not need to be replaced, since Medtronic’s screening has concluded that more than 99% of the devices included in the recall “function as intended.” Instead, clinicians should continue to regularly inspect the catheters to ensure they’re working properly.

The recall, which began at the end of November, builds on another Class I event that Medtronic initiated in June. In that case, more than 1 million hemodialysis catheters were recalled for the same potential leakages within the catheter hub.

The majority of devices included in the earlier recall were sold under Covidien’s Palindrome product line, with only one Mahurkar version: the Maxid chronic carbothane catheter. As of June, when the recall began, Medtronic had received only one complaint related to the issue, with no reports of injury or death.