The U.S. Food and Drug Administration (FDA) has issued a warning letter to Unomedical, a Convatec company that manufactures insulin infusion sets used with pumps from Medtronic, Tandem Diabetes, and Beta Bionics. The letter follows an inspection of Unomedical's manufacturing facility in Reynosa, Mexico, and raises concerns about the company's quality systems and how it has handled reports of faulty devices.

At the center of the FDA's concerns are leaking infusion sets, a problem that can have serious consequences for insulin pump users. When an infusion set leaks, insulin does not get properly delivered, which can lead to dangerous blood sugar spikes and potentially life-threatening diabetic ketoacidosis (DKA). Between January 2023 and June 2025, Unomedical received more than 5,000 leak-related complaints, many involving reports of hyperglycemia and DKA.

The FDA took issue with how Unomedical managed those complaints. From June 2023 to June 2025, the company closed more than 41,000 complaints without an investigation, citing a lack of lot numbers in the reports. This happened even when complaints described serious issues such as leaks, adhesive failures, infections, and death. Unomedical has since said it will review complaints involving serious injury or death and provide additional staff training.

Regulators also raised concerns about corrective actions, citing the VariSoft infusion sets for Tandem pumps as a key example, where 210 tubing detachment complaints led to over 80 hyperglycemia reports before a recall was issued in October 2023. Missed deadlines for reporting serious adverse events were flagged as well.

For now, there are no restrictions on manufacturing or distribution. Convatec, the parent company of Unomedical, stated the warning letter focuses on reporting procedures and quality systems, and that the company is actively working with the FDA to strengthen its processes. For the diabetes community that relies on infusion sets daily, this letter serves as an important reminder to stay alert to any signs of delivery issues and to report concerns promptly. We cover how to spot insulin disturbances and leaky sites in our episode of Optimizing Diabetes Tech which you can listen to here.

Have you encountered leaky infusion sets? Let us know your experience in the comments.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.