Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error
Insulet Corporation is recalling 1,773 Omnipod DASH Insulin Management Systems (mmol/L configuration) because the Bolus Calculator may fail to accurately subtract insulin on board after two months of use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the defect involves a critical safety feature (Bolus Calculator) in a medical device used for insulin delivery, which poses a significant risk of harm if the calculation is inaccurate.
Plain-English summary
Insulet Corporation is recalling 1,773 units of the Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011. The affected devices are identified by UDI PT000011 10385082000146 and Lot Numbers L000200, L000201, L000203, L000209, and L000210. These products were distributed to Italy, the Netherlands, and the UK.
The recall is due to a data processing issue in the Personal Diabetes Manager (PDM). After the device has been in use for about two months, data processing can be slowed, causing the Bolus Calculator to fail to accurately subtract the correct amount of insulin on board (IOB) before suggesting a bolus amount. This device is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Consumers who have these specific lot numbers should contact Insulet Corporation for further instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - 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
- 1,773
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 (6)
- UDI: PT000011 10385082000146
- Lot Numbers: L000200
- L000201
- L000203
- L000209
- L000210
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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