FDA announces recall of infusion sets due to defect that puts diabetes patients at risk

The U.S. Food and Drug Administration (FDA) has announced that Unomedical A/S is recalling thousands of boxes of its VariSoft Infusion Sets designed to assist with the delivery of insulin to diabetes patients. The FDA considers this a Class I recall, which means using these devices “may cause serious injuries or death.”

The VariSoft Infusion Sets are used with Tandem’s insulin pumps to deliver insulin to patients subcutaneously. The recall was put in place due to a risk that the connector could detach from the rest of the infusion set during use.

“If this occurs, insulin may continue to flow through the tubing that is now disconnected from the patient and the insulin pump would not recognize an infusion set problem and would not alert users,” according to the FDA’s advisory. “The defect reported was caused by damage to the connector piece during manufacturing, resulting in the connector becoming detached more easily from the insulin set than expected. Disconnections occurring during sleep, or when otherwise not detected, may lead to hyperglycemia unless it is noticed and reconnected promptly.”

The FDA noted that pediatric and elderly patients may face an especially high risk of complications because they are the least likely to notice the connector detaching from the rest of the device.