Recall Z-0154-2023 · LZG Pump, Infusion, Insulin
Insulet Corporation
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
| Date | Nov 15, 2022 (initiated Oct 17, 2022) |
| Status | Terminated |
| Reason | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM. |
| Root cause | Device Design |
| Action | On October 17, 2022, the firm notified customers via Urgent Medical Device Correction letters sent via email. The firm followed up with physical mailers. Customers will receive updated Omnipod DASH PDMs in the coming months. Customers do not need to call to receive an updated device, one will automatically be shipped to you when available. Customers were provided with additional precautions to follow until they receive replacement units. If you have any questions regarding the information provided in this Medical Device Correction, please visit our website at www.omnipod.com/insulet-alerts |
| Quantity | 248,288 US; 167,802 OUS |
| Distribution | Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System Insulet Corporation, Aug 13, 2021 |