FDA-Device2020-04-01Class II
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
Hazard
In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
Sold states
US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom.
Affected count
32756 (US), 1420 (International)
Manufactured in
100 Nagog Park, N/A, Acton, MA, United States
Products
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2020More Insulet Corporation recalls
- FDA-Device2026-07-08Insulet Omnipod 5 Pods recalled for insulin leakage risk due to manufacturing defect
- FDA-Device2026-07-08Insulet Omnipod DASH Pod recalled for insulin leakage risk during manufacturing
- FDA-Device2026-07-08Insulet Omnipod Eros insulin pump pods recalled for potential under-delivery due to cannula damage
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