Fresenius Stay-Safe Catheter Extension Set Recall Issued Due to Toxic Compound Exposure Risks

Federal health officials warn that more than 2.1 million Fresenius catheter extensions may expose patients to toxic chemicals during hemodialysis, increasing the risk of infertility, liver issues, and other health problems in patients.

The U.S. Food and Drug Administration (FDA) announced the Fresenius Medical Care Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter recall on April 25, warning the catheters may leach the toxic chemical, non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA).

Catheters are used during hemodialysis treatment to filter waste and water from the blood and infuse fluids into the bloodstream in patients with acute or chronic end-stage kidney disease who are undergoing peritoneal dialysis both in clinic settings and at home.

The recalled catheter extension sets and adapters connect peritoneal dialysis catheters or catheters inserted into patients’ abdominal cavities to peritoneal dialysis systems.

Fresenius first issued a device correction for the catheter extensions on January 23, but the FDA gave the action a Class I designation this week. A Class I recall is the most serious type of recall, indicating that the FDA believes problems with the devices may cause serious injuries or death.

So far, no injuries or deaths have been reported in connection to the recall.

The FDA warns that NDL-PCBA, a toxic chemical, was detected leaching from the silicone tubing for the catheter extensions. It can enter patients through the tissue that lines the abdominal wall through the dialysate solution.

The risk is highest for patients who weigh less than 88 pounds, who may be exposed to levels of NDL-PCBAs that exceed allowable safety limits. The warning does not include patients who weigh more than 88 pounds, as they face less of a risk of being exposed to high levels of the toxic chemical.

Exposure to NDL-PCBAs can cause serious health consequences months and even years after exposure. Patients can experience endocrine dysfunction, liver issues, neurobehavioral changes, skin problems like acne and rashes, and infertility in men.

The recall does not require the catheter extension kits to be returned to Fresenius, but instead corrects instructions for how to use the kits. The new instructions advise patients to use the shortest length of catheter extension possible when treating patients under 88 pounds, including infants and neonates.

The affected catheter extension kits were distributed from March 5, 2003, to January 25, 2024.

Customers with questions can contact Fresenius’s Global Medical Information and Education Office at 855-616-2309.

Catheter Recalls 

In recent years the FDA issued a number of other catheter recalls due to various manufacturing defects. Most involved issues with catheter tips that are prone to breaking off during medical procedures and potentially injuring patients.

In 2022, more than 1 million Medtronic catheters were recalled due to leaks during use, increasing the risk of blood clots and other serious health problems during hemodialysis treatments.

In 2023, the FDA issued a Class I recall for Medtronic catheters due to the risk of tubing leaks, which could also cause blood clots and a lack of clean blood being filtered back through the body during hemodialysis treatments.

Most of the catheter recalls issued were classified as Class I recalls by the FDA due to their risks to patients.