Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions
Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (hypoglycemia or hyperglycemia) from a medical device, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Insulet Corporation is recalling the Omnipod DASH Personal Diabetes Manager (PDM) due to a software issue that may cause the device to suggest an inaccurate bolus amount. This can occur if the device uses 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.
The affected units are software version 1.0.50 and earlier. The recall covers 32,756 units distributed in the United States and 1,420 units distributed internationally to Italy, the Netherlands, and the United Kingdom. If a user delivers an inaccurate bolus, it may lead to hypoglycemia or hyperglycemia.
Consumers should check their device software version and lot number against the recall list. If the device is affected, users should contact Insulet Corporation for instructions on how to proceed with the recall and software update.
The recalled product
- Product
- 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
- Manufacturer
- Insulet Corporation
Distribution
Distributed nationwide across the United States.
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