Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error
Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.
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 involves a medical device intended for insulin delivery where a calculation error could lead to incorrect dosing. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Insulet Corporation is recalling 400 units of the Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010. The affected units are identified by UDI PT - 000010 - 10385082000139 and Lot Number L000202. These products were distributed to Italy, the Netherlands, and the UK.
The recall is due to a software issue in the Personal Diabetes Manager (PDM). After the device has been in use for approximately two months, data processing can slow down, causing the Bolus Calculator to fail to accurately subtract the correct amount of insulin on board (IOB) before suggesting a bolus amount.
Consumers who have these specific units should stop using the affected PDM for bolus calculations and contact Insulet Corporation for instructions on how to proceed.
The recalled product
- Product
- Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
- Manufacturer
- Insulet Corporation
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: PT - 000010 - 10385082000139
- Lot Numbers: L000202
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Insulet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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