Health product recall

Omnipod Dash System

Last updated

Summary

Product
Omnipod Dash System
Issue
Medical devices - Performance
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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