11/14/2022
On November 14, 2022 Insulet Corporation 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.
Insulet received 24 reports that the charging port (USB-C port), or cable (USB cable) for the product 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. According to Insulet, no serious injuries have been reported to Insulet as a result of this issue.
Insulet has advised that all affected 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.
CVS/Caremark® Response: CVS Caremark® Mail Service Pharmacy is sending letters to impacted prescribers and patients.
If you have questions, please call Insulet’s dedicated Customer Care team at 1-800-641-2049, which is available in the U.S. 24 hours a day, 7 days a week. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.
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