Insulet (NASDAQ: PODD) faces Omnipod 5 pod correction with up to $40M cost

Rhea-AI Filing Summary

Insulet Corporation announced a voluntary medical device correction for specific lots of its Omnipod® 5 Pods in the U.S. after identifying a manufacturing issue that can cause small tears in internal tubing and under-delivery of insulin.

The company has received 18 reports of serious adverse events tied to high blood glucose and diabetic ketoacidosis, but no deaths, and has notified the FDA. The affected lots represent about 1.5% of annual Omnipod 5 pod production, and Insulet does not expect shipment or new-patient-start disruptions. Customers can check lot numbers online and obtain free replacement Pods.

Insulet currently expects to incur up to $40 million of related costs in 2026, which will be excluded from adjusted results, and it is not changing previously issued 2026 guidance.

Positive

• None.

Negative

• Up to $40 million in 2026 costs related to the voluntary Omnipod® 5 pod medical device correction, even though these expenses will be excluded from adjusted results.
• Product safety and regulatory risk from a manufacturing defect causing insulin under-delivery, with 18 serious adverse events including diabetic ketoacidosis and potential future disputes, claims, or proceedings.

Insights

Medical device & earnings impact analyst

Insulet flags Omnipod 5 pod safety issue with up to $40M 2026 cost.

Insulet is addressing a manufacturing defect in specific Omnipod® 5 Pod lots that can cause insulin leakage and under-delivery, leading to high blood glucose and, in severe cases, diabetic ketoacidosis. The company reports 18 serious adverse events, including hospitalizations, but no deaths.

Financially, management expects up to $40 million of correction-related costs in 2026, all treated as adjustments and excluded from non-GAAP results, while maintaining its 2026 guidance. The affected lots account for about 1.5% of annual Omnipod 5 pod production, and Insulet does not anticipate supply or new-patient-start disruption.

Regulatory and legal risk remain important considerations, as the FDA has been notified and the company acknowledges potential disputes, claims, or proceedings. Future SEC reports, including the Form 10-K for the year ended December 31, 2025, are cited as key sources for evolving risk disclosures.

0001145197FALSE00011451972026-03-122026-03-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(D) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  March 12, 2026

INSULET CORPORATION

(Exact name of registrant as specified in its charter)

Delaware

001-33462

04-3523891

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

100 Nagog Park

Acton

Massachusetts

01720

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (978) 600-7000

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company			☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised accounting standards provided pursuant to Section 13(a) of the Exchange Act.			☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 Par Value Per Share

PODD

The NASDAQ Stock Market, LLC

Item 7.01 Regulation FD Disclosure

On March 12, 2026, Insulet Corporation (the “Company”) issued a press release regarding a voluntary medical device correction. A copy of the press release is furnished herewith as Exhibit 99.1.

While it is too early to ascertain the exact cost of the voluntary medical device correction, the Company currently expects to incur up to $40 million of costs associated with this event, all in 2026. These costs will be excluded from adjusted results. Accordingly, Insulet is not changing its previously issued 2026 guidance as a result of this voluntary action.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section. The information in this Current Report shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.

Forward-Looking Statements

This current report on Form 8-K includes certain forward-looking statements within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, including statements concerning the Company’s plans or expectations regarding the voluntary medical device correction, effects of the voluntary medical device correction on the Company’s business, operations, and financial performance or guidance, and expected costs of the voluntary medical device correction, and involve known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s control, that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, plans, guidance, estimates and projections, including (but not limited to) the financial, operational, and reputational impact and costs of the voluntary medical device correction, future actions by the FDA and other regulatory bodies, the possibility that the voluntary medical device correction could subject the Company to disputes, claims or proceedings that may adversely affect its business and financial operation and other factors detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2025. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this report. The forward-looking statements made in this report are made only as of the date of this report, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances except as required by applicable law.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

No.						Exhibit
99.1						Press Release dated March 12, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned thereunto duly authorized.

INSULET CORPORATION

March 12, 2026

By:

/s/ John W. Kapples

Name:

John W. Kapples

Title:

Senior Vice President, General Counsel

Exhibit 99.1

Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.

•Medical Device Correction impacts only specific lots of Omnipod® 5 Pods

•Customers can visit omnipod.com/check-pods to check lot numbers and request replacement Pods at no cost

•All other Omnipod® 5 Pods and Omnipod® products remain safe to use

ACTON, Mass., March 12, 2026 -- Insulet Corporation (NASDAQ: PODD) (“Insulet” or the “Company”) today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States, and all other Omnipod® 5 Pods and Omnipod® products remain safe to use.

Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended.

If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment.

Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported.

This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.

Following its investigation, Insulet has implemented updates to its manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of its products. The Pods involved in this correction represent approximately 1.5% of annual Omnipod® 5 pod production globally.

Insulet continues to manufacture and ship Omnipod® 5 Pods and does not anticipate disruption to customer shipments, product availability, or new patient starts.

The U.S. Food and Drug Administration (FDA) has been notified of this action. Patient safety and product quality remain Insulet’s highest priorities.

Important Information for Omnipod® 5 Users

Customers should visit omnipod.com/check-pods to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.

If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.

Customers who have questions or need assistance may contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat at omnipod.com/current-podders.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod® product platform. The Omnipod® Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod® 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod® 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod® technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

Forward-Looking Statement:

This press release includes certain forward-looking statements within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, including statements concerning the Company’s plans or expectations regarding the voluntary medical device correction and effects of the voluntary medical device correction on the Company’s business, operations, and financial performance or guidance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s control, that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, plans, guidance, estimates and projections, including (but not limited to) the financial, operational, and reputational impact and costs of the voluntary medical device correction, future actions by the FDA and other regulatory bodies, the possibility that the voluntary medical device correction could subject the Company to disputes, claims or proceedings that may adversely affect its business and financial operation and other factors detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2025. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this press release. The forward-looking statements made in this press release are made only as of the date of this press release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances except as required by applicable law.

Contacts

Media: Cristal Downing Chief Corporate Affairs Officer pr@insulet.com

Investor Relations: Clare Trachtman Vice President, Investor Relations ir@insulet.com

FAQ

What voluntary medical device correction did Insulet (PODD) announce for Omnipod 5 Pods?

Insulet initiated a voluntary medical device correction for specific lots of Omnipod® 5 Pods in the U.S. after detecting a manufacturing issue that can cause internal tubing tears, insulin leakage, and under-delivery, potentially leading to high blood glucose and diabetic ketoacidosis in severe cases.

How much does Insulet (PODD) expect the Omnipod 5 device correction to cost?

Insulet currently expects to incur up to $40 million of costs related to the Omnipod® 5 pod medical device correction, all in 2026. These expenses will be excluded from adjusted results, and the company is not changing its previously issued 2026 financial guidance due to this voluntary action.

Which Insulet (PODD) products are affected by the Omnipod 5 correction and how large is the impact?

The action applies only to specific identified lots of Omnipod® 5 Pods distributed in the United States. Insulet states the affected Pods represent approximately 1.5% of its annual Omnipod 5 pod production globally, and all other Omnipod 5 Pods and Omnipod products remain safe to use.

How can Omnipod 5 users check if their Pods are affected and get replacements?

Customers can visit omnipod.com/check-pods to enter Pod lot numbers and see if they are included in the voluntary correction. If affected, users may request replacement Pods at no cost and are advised to discontinue any in-use Pod from affected lots and switch to an unaffected Pod.

Will Insulet’s (PODD) Omnipod 5 device correction disrupt product supply or new patient starts?

Insulet states it continues to manufacture and ship Omnipod® 5 Pods and does not anticipate disruption to customer shipments, overall product availability, or new patient starts. The company has implemented manufacturing and quality-control updates to better detect and prevent the identified tubing defect.

What regulatory and safety information did Insulet (PODD) provide about the Omnipod 5 issue?

Insulet reports 18 serious adverse events, including diabetic ketoacidosis and hospitalizations, but no deaths associated with the affected Pods. The U.S. Food and Drug Administration has been notified, and Insulet warns that future regulatory actions and potential disputes or claims could adversely affect its business and financial operations.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 13.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.7 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 21.4 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 12.2 KB