Omnipod Dash System
Brand(s)
Last updated
Summary
Product
Omnipod Dash System
Issue
Medical devices - Performance issue
What to do
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Insulet Corporation
100 Nagog Park, Acton, Massachusetts, United States, 01720
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-72079
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