Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system.
Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 app installed.
The company took its actions voluntarily with the knowledge of the FDA. It received 24 reports of the Omnipod 5 controller charging port (USB-C port) or cable (USB) melting, deforming or discoloring. This comes as a result of heat generated by a poor connection between the cable and port, according to a news release.
Excess heat may cause minor burns if users touch the affected areas of the controller. The issue may potentially lead to fire as well. Insulet received no reports of serious injuries as a result of the issue to date. The company notified Omnipod 5 users by email with instructions for detecting and reducing the risk of this issue.
The latest-generation Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals 6 years of age and older. Last month, the FDA cleared Omnipod 5 for individuals aged 2 and older.
In August, the FDA cleared Omnipod 5 for individuals aged 2 and older. It picked up CE mark for the same age range in September.
Insulet’s correction follows a recent voluntary global safety notice to warn of battery problems with its Omnipod Dash system. Some users reported battery swelling and fluid leaking from the battery. In rare cases, they reported extreme overheating, which may pose a fire hazard.