FDA Enforcement
Class II
Ongoing
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
Recall: Z-0423-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0423-2023
- Event ID
- 91127
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Insulet Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2022
- Initiation Date
- November 14, 2022
- Classification Date
- December 7, 2022
- Address
- 100 Nagog Park, N/A, Acton, MA, 01720-3440, United States
Description
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
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.
Code Info
ALL serial numbers/ controller lots are currently in scope of this recall
Distribution
Domestic distribution nationwide.
Quantity
129,086