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.
FDA Recall Z-0154-2023 · Posted 2022-11-15
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Recalling FirmInsulet Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2022-10-17
Date Terminated2024-09-17
Product Quantity248,288 US; 167,802 OUS
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.
Firm 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 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
Distribution Pattern
Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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