United States
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. These actions are taken voluntarily with the knowledge of the FDA. Insulet has received 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port.
The excess heat may cause minor burns if those areas of the Controller are touched or could lead to fire. No serious injuries have been reported to Insulet as a result of this issue.
Omnipod 5 users are being notified by email with instructions on how to detect and reduce the risk of an issue with the charging port or cable.
In case you experienced issues with this product, it is important to report it.
Company name: Insulet Corporation
Brand name: Insulet Corporation Omnipod
Product recalled: Automated Insulin Delivery System
Reason of the recall: Issue with the Omnipod 5 Controller charging port and cable
FDA Recall date: November 15, 2022
Source:
www.fda.gov
