Recall Z-0154-2023
Insulet Corporation · initiated October 17, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0154-2023
- Initiated
- October 17, 2022
- Posted by FDA
- November 15, 2022
- Terminated
- September 17, 2024
- Product code
- LZG – Pump, Infusion, Insulin
- Quantity
- 248,288 US; 167,802 OUS
- Distribution
- Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
- Recalling firm
- Insulet Corporation, Acton, MA