Insulet (PODD) issued voluntary Medical Device Correction notice for its Omnipod DASH Personal Diabetes Manager - StreetInsider.com

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Insulet (NASDAQ: PODD) disclosed:

On October 17, 2022, Insulet Corporation (the “Company”) issued a voluntary Medical Device Correction announcement for its Omnipod DASH® Personal Diabetes Manager (“PDM”) relating to the Omnipod DASH PDM battery. Insulet volition regenerate the PDMs for each existent Omnipod DASH users globally owed to reported issues which whitethorn hap if the PDM artillery is charged to afloat capableness oregon for extended periods of time. The Company presently estimates an aggregate complaint successful the scope of $35 cardinal to $45 cardinal with the bulk impacting outgo of gross successful the 3rd 4th of 2022 and the remainder chiefly impacting operating expenses successful the 4th fourth of 2022 and fiscal twelvemonth 2023.

Additionally, excluding the related charges, the Company is not changing its yearly gross borderline oregon adjusted operating borderline guidance provided connected August 4, 2022.

This voluntary Medical Device Correction announcement does not impact the Omnipod DASH Pods, the Omnipod® Insulin Management System, oregon the Omnipod® 5 Automated Insulin Delivery System.

A transcript of the announcement sent to customers successful the United States is attached arsenic grounds 99.1 to this Form 8-K. The announcement is besides posted connected the Company’s website astatine www.omnipod.com/insulet-alerts.