FDA Device Recall Z-0591-2024

Insulet Corporation · Acton, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

Lot / serial / GTIN: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206

Quantity: 27000 users

Reason for recall

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Recall record

Recall number: Z-0591-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK.
Recall initiated: 2023-11-30
Classified by FDA Center: 2024-01-04
FDA published: 2024-01-10
Recalling firm: Insulet Corporation
Firm location: Acton, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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