Insulet clarifies adverse event counts on device issue

Insulet Corporation furnished an update and clarification related to its voluntary Medical Device Correction.

Rhea-AI Filing Summary

Insulet Corporation furnished an update and clarification related to its voluntary Medical Device Correction. The Company previously reported 18 Serious Adverse Events and later expanded communications on April 10, 2026 to include 13 expired lots, stating this does not change its earlier estimated financial impact. The updated communication referenced 29 confirmed Serious Adverse Events. The Company also explained that an FDA website statement citing 476 serious injuries actually refers to 476 Medical Device Reports potentially related to the correction, rather than 29 confirmed Serious Adverse Events. The information is furnished under Item 7.01 and is not deemed filed under the Exchange Act.

Insights

Medical device risk analyst

Insulet clarifies safety-report numbers without changing its stated financial impact.

Insulet provides more detail around its voluntary Medical Device Correction by distinguishing between confirmed Serious Adverse Events and broader Medical Device Reports referenced by the FDA. This distinction helps separate verified clinical outcomes from a wider pool of potentially related reports.

The Company now cites 29 confirmed Serious Adverse Events, while confirming that the FDA’s 476 figure represents Medical Device Reports potentially tied to the issue. It also states that adding 13 expired lots to the communication does not alter its previously communicated estimated financial impact.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Initial Serious Adverse Events: 18 reports Additional expired lots: 13 lots Confirmed Serious Adverse Events: 29 events +1 more

4 metrics

Initial Serious Adverse Events 18 reports Reported in March 12, 2026 press release

Additional expired lots 13 lots Added in April 10, 2026 customer communication

Confirmed Serious Adverse Events 29 events Stated in updated communication

Medical Device Reports 476 reports Figure referenced by FDA as of April 17

Key Terms

Medical Device Correction, Serious Adverse Events, Medical Device Reports, Item 7.01

4 terms

Medical Device Correction regulatory

"issued and filed with the SEC a press release regarding a voluntary Medical Device Correction"

A medical device correction is an action taken by a manufacturer or regulator to fix a safety or performance problem in an already-distributed medical device, such as a repair, software update, label change, or retrofit. It matters to investors because corrections can signal safety risk, trigger costs, regulatory scrutiny, lost sales or reputational damage—similar to a software patch or auto recall that interrupts normal business and may affect future revenue and liability exposure.

Serious Adverse Events medical

"the Company reported that it had received 18 reports of Serious Adverse Events"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

Medical Device Reports regulatory

"referring to 476 Medical Device Reports potentially related to the Medical Device Correction"

Item 7.01 regulatory

"The information in this Item 7.01 shall not be deemed “filed”"

Item 7.01 is the Regulation FD Disclosure entry on the SEC Form 8‑K, used when a public company has made material nonpublic information public and needs to report how that disclosure was handled (for example by furnishing a press release, presentation, or webcast). It tells investors that important information was released to the market and where to find the disclosure, helping ensure everyone had equal access to news that could affect the company’s stock price, like broadcasting a press briefing so no one gets a private scoop.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Insulet (PODD) disclose about its voluntary Medical Device Correction?

Insulet disclosed an update and clarification on its voluntary Medical Device Correction. It reiterated earlier information, expanded communications on April 10, 2026, and clarified how its confirmed Serious Adverse Events relate to a larger set of Medical Device Reports referenced by the FDA.

How many Serious Adverse Events has Insulet (PODD) confirmed?

Insulet referenced 29 confirmed Serious Adverse Events related to the Medical Device Correction. This figure reflects cases the Company has confirmed, distinguishing them from a larger number of potentially related Medical Device Reports cited by the U.S. Food and Drug Administration.

What is the significance of the FDA’s reference to 476 serious injuries for Insulet (PODD)?

The FDA website language cited 476 serious injuries with no deaths. Insulet clarified that this figure represents 476 Medical Device Reports potentially related to the Medical Device Correction, rather than 29 confirmed Serious Adverse Events previously described in the Company’s communications.

Did Insulet’s (PODD) update on expired lots change its estimated financial impact?

No, Insulet stated that adding 13 expired lots in its April 10, 2026 communication does not affect its previously communicated estimated financial impact of the Medical Device Correction. The update changes the scope of lots discussed, not the Company’s earlier financial assessment.

Is Insulet’s (PODD) Medical Device Correction disclosure considered filed or furnished?

The information is furnished under Item 7.01 of the Exchange Act. Insulet specified that this information shall not be deemed filed for Section 18 liability and is not incorporated by reference into other Securities Act filings unless specifically referenced.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 04/29/2026 - 04:04 PM Learn about SEC filing dates

0001145197FALSE00011451972026-04-292026-04-29

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):  April 29, 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 and filed with the SEC a press release regarding a voluntary Medical Device Correction. In that press release, the Company reported that it had received 18 reports of Serious Adverse Events.

On April 10, 2026, the Company updated communications to customers and posted on its website information regarding this device correction. This updated communication included the addition of 13 expired lots. The addition of these expired lots has no impact on the Company’s previously communicated estimated financial impact. The communication also noted 29 confirmed Serious Adverse Events.

On April 29, 2026, the U.S. Food and Drug Administration (FDA) included language on their website that said “As of April 17, Insulet has reported 476 serious injuries and no deaths associated with this issue”. The Company confirmed that the FDA statement is referring to 476 Medical Device Reports potentially related to the Medical Device Correction rather than the 29 confirmed Serious Adverse Events.

The information in this Item 7.01 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.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

No.						Exhibit
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

April 29, 2026

By:

/s/ John W. Kapples

Name:

John W. Kapples

Title:

Senior Vice President, General Counsel

Filing Exhibits & Attachments

3 documents

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