Insulet ( PODD ) has issued a voluntary medical device correction notice for its Omnipod DASH Personal Diabetes Manager

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island (NASDAQ: PODCAST) detected:

On October 17, 2022, Insulet Corporation (the “Company”) issued a voluntary medical device correction notice for its Omnipod DASH® Personal Diabetes Manager (“PDM”) regarding the Omnipod DASH PDM Battery. Insulet will replace the PDMs for all current Omnipod DASH users worldwide due to reported issues that may occur if the PDM battery is charged to full capacity or over an extended period of time. The company currently estimates the total costs to be in the range of $35 million to $45 million, with the majority impacting cost of revenue in the third quarter of 2022 and the remainder primarily impacting operating expenses in the fourth quarter of 2022 and fiscal year 2023.

Additionally, excluding related costs, the Company is not changing its annual gross margin or adjusted operating margin guidance dated August 4, 2022.

This Voluntary Medical Device Correction Notice does not affect the Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.

A copy of the notice sent to customers in the United States is attached as Exhibit 99.1 to this Form 8-K. The notice is also posted on the Company’s website at www.omnipod.com/insolet-alerts.