Recall Z-0423-2023 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
| Date | Dec 7, 2022 (initiated Nov 14, 2022) |
| Status | Open, Classified |
| Reason | The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan. |
| Root cause | Device Design |
| Action | On November 14, 2022, the firm initiated their Press Release at https://investor.insulet.com/news-releases/news-release-details/insulet-issues-nationwide-voluntary-medical-device-correction and notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to monitor their Omnipod 5 Controller for the following issues: - Charging port or charging cable appears melted, deformed, or discolored - Controller experiences extreme overheating (uncomfortable to hold) or emits an odor while charging If customers experience any of the issues above, they shoul |
| Quantity | 129,086 |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203768 | Omnipod 5 ACE Pump (Pod) Insulet Corporation, Jan 27, 2022 |