Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter from the Food and Drug Administration in January.
Inspectors raised concerns with leaking infusion sets, which can pose a risk of insulin under-delivery, potentially leading to life-threatening complications like diabetic ketoacidosis. Regulators called for Unomedical to address problems with validating its devices, addressing complaints and providing timely adverse event reports to the FDA.
The warning letter followed a remote regulatory assessment of Unomedical’s facility in Reynosa, Mexico, last summer.
Unomedical supplies infusion sets to insulin pump makers including Medtronic, Tandem Diabetes Care and Beta Bionics. In a Feb. 3 statement, Convatec said the letter focuses on reporting procedures and quality protocols and does not place restrictions on producing, marketing or distributing any of Unomedical’s products.
Problems with testing, uninvestigated complaints
Inspectors found validation lacking for a process that Unomedical uses to test for leaks in its infusion sets. Between January 2023 and June 2025, Unomedical received more than 5,000 complaints related to leaking infusion sets, including reports of high blood sugar and diabetic ketoacidosis, according to the warning letter.
The FDA also flagged problems with Unomedical’s process for handling complaints. The company closed more than 41,000 complaints received between June 2023 and June 2025 without investigation because the lot numbers were missing. The uninvestigated complaints include allegations of leaks, loss of physical integrity, adhesive failures, infections and death.
Unomedical told the FDA in its responses that it plans to conduct a retrospective review of complaints involving serious injury or death by January and conduct additional training on complaint handling by May.
Not enough validation of fixes
The warning letter also said Unomedical did not do enough to validate that it had fixed a problem after taking a corrective action.
For example, the company received 210 complaints between December 2022 and October 2023 of its Varisoft infusion set tubing, which it makes for Tandem, detaching from the connector. The problem resulted in more than 80 reports of hyperglycemia.
Unomedical recalled the device in October 2023, more than 11 months after it became aware of the product defect, according to the FDA. After determining the issue was caused by a defective manufacturing machine, Unomedical took corrective actions and closed the case in May 2025. However, the company did not include several complaints of hyperglycemia in its verification check.
Unomedical opened another corrective action in February 2025 to address more than 3,000 complaints of leaking with its extended wear infusion sets.
Unreported adverse events
Finally, Unomedical also failed to report adverse events within the required 30 days. A complaint suggested that four of the company’s AutoSoft XC infusion sets leaked during use, resulting in elevated blood glucose readings. Unomedical makes the AutoSoft XC devices for Tandem. Unomedical failed to submit corresponding reports for each of these serious injury events despite learning about them in September 2024, according to the warning letter.
