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Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5
About this update from Insulet Corporation
[{"type":"text","content":" ACTON, Mass.--(BUSINESS WIRE)--\nInsulet 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.\n\nInsulet 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.\n\nOmnipod 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. Users who experience any issue should contact Insulet’s dedicated Customer Care team at 1-800-641-2049, which is available 24 hours a day, 7 days a week. Alternatively, Omnipod 5 users can utilize the FDA’s MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), by regular mail, or by fax (1-800-FDA-0178).\n\nAdditional information, including instructions to customers to mitigate risk, can be found on the Company’s website at www.omnipod.com/insulet-alerts.\n\nAbout Insulet Corporation:\n\nInsulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s latest innovation, the Omnipod® 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and is fully...