Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller - Business Wire

ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet oregon the Company), contiguous announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System due to the fact that of an contented with the Omnipod 5 Controller charging larboard and cable. This does not interaction the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, oregon compatible Android smartphone devices that person the Omnipod 5 App installed. These actions are taken voluntarily with the cognition of the FDA.

Insulet has received 24 reports that the Omnipod 5 Controller charging larboard (USB-C port) oregon cablegram (USB cable) are melting, deforming, oregon discoloring owed to vigor generated by a mediocre transportation betwixt the cablegram and the port. The excess vigor whitethorn origin insignificant burns if those areas of the Controller are touched oregon could pb to fire. No superior injuries person been reported to Insulet arsenic a effect of this issue.

Omnipod 5 users are being notified by email with instructions connected however to observe and trim the hazard of an contented with the charging larboard oregon cable. Users who acquisition immoderate contented should interaction Insulet’s dedicated Customer Care squad astatine 1-800-641-2049, which is disposable 24 hours a day, 7 days a week. Alternatively, Omnipod 5 users tin utilize the FDA’s MedWatch Adverse Event Reporting programme either online (www.fda.gov/medwatch/report.htm), by regular mail, oregon by fax (1-800-FDA-0178).

Additional information, including instructions to customers to mitigate risk, tin beryllium recovered connected the Company’s website astatine www.omnipod.com/insulet-alerts.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered successful Massachusetts, is an innovative aesculapian instrumentality institution dedicated to simplifying beingness for radical with diabetes and different conditions done its Omnipod merchandise platform. The Omnipod Insulin Management System provides a unsocial alternate to accepted insulin transportation methods. With its simple, wearable design, the disposable Pod provides up to 3 days of non-stop insulin delivery, without the request to spot oregon grip a needle. Insulet’s latest innovation, the Omnipod^® 5 Automated Insulin Delivery System, is simply a tubeless automated insulin transportation system, integrated with a continuous glucose show to negociate humor sweetener with nary aggregate regular injections, zero fingersticks, and is afloat controlled by a compatible idiosyncratic smartphone. Insulet besides leverages the unsocial plan of its Pod by tailoring its Omnipod exertion level for the transportation of non-insulin subcutaneous drugs crossed different therapeutic areas. For much information, delight visit: insulet.com and omnipod.com.

Forward-Looking Statement:

This property merchandise whitethorn incorporate forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, oregon strategies regarding the future. These forward-looking statements are based connected its existent expectations and beliefs concerning aboriginal developments and their imaginable effects connected Insulet. There tin beryllium nary assurance that aboriginal developments affecting Insulet volition beryllium those that it has anticipated. These forward-looking statements impact a fig of risks, uncertainties (some of which are beyond its control) oregon different assumptions that whitethorn origin existent results oregon show to beryllium materially antithetic from those expressed oregon implied by these forward-looking statements, and different risks and uncertainties described successful its Annual Report connected Form 10-K, which was filed with the Securities and Exchange Commission connected February 24, 2022 successful the conception entitled "Risk Factors," and successful its different filings from clip to clip with the Securities and Exchange Commission. Should 1 oregon much of these risks oregon uncertainties materialize, oregon should immoderate of its assumptions beryllium incorrect, existent results whitethorn alteration successful worldly respects from those projected successful these forward-looking statements. Insulet undertakes nary work to publically update oregon revise immoderate forward-looking statements.

©2022 Insulet Corporation. Omnipod, Omnipod DASH and Omnipod 5 are trademarks oregon registered trademarks of Insulet Corporation successful the United States of America and different assorted jurisdictions. All rights reserved.