18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembl
FDA device recall Z-0154-2023 · posted 2022-11-15 · Terminated
Recall details
- Recalling firm
- Insulet Corporation
- Reason for recall
- 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.
- Action taken
- 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 or call 1-800-641-2049 to speak with a dedicated staff member of the Insulet Customer Care team who will be available 24 hours a day, 7 days a week.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 248,288 US; 167,802 OUS
- Distribution
- Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
- Date initiated
- 2022-10-17
- Date posted
- 2022-11-15
- Date terminated
- 2024-09-17
- Location
- Acton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575) | Insulet Corporation | 2021-08-13 |