News

Oct 30, 2024

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

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.

Unomedical A/S is recalling certain VariSoft Infusion Sets due to a significant manufacturing defect.

One patient injury has been reported due to this issue. There have been no patient deaths.

The recall includes more than 13,000 boxes of infusion sets distributed to customers from October 2022 to September 2023. A total of 10 infusion sets are packaged inside each box.

A full list of impacted model numbers and lot numbers is available here.

Unomedical A/S warned Tandem Diabetes Care about this issue back in October 2023. Customers are being instructed not to use any devices included in this recall.

“If all remaining stock is from the affected lots, please immediately contact your healthcare provider for guidance and instant replenishment,” according to the advisory.

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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