Omnipod Dash System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Omnipod Dash, Pdm, Personal Diabetes Manager |
More than 10 numbers, contact manufacturer. |
PDM-CAN-D001-MM |
Omnipod Dash, Personal Diabetes Manager Kit |
139723 |
SKT-CAN-D001-MM |
Issue
Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events). The health hazard evaluation (HHE) was completed on October 10, 2022 with an analysis of possible causes and hazardous situations with the information that was known at the time.
Recall start date: October 17, 2022
Additional information
Details
Insulet Corporation
100 Nagog Park, Acton, Massachusetts, United States, 01720
Get notified
Receive notifications for new and updated recalls and alerts by category.