FDA Aware of Insulet Product Defect Leading to 24 Serious Injuries
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
The FDA said it is aware that Insulet issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold. The affected devices are Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and Omnipod Insulin Management System. Insulet identified that some Pods from specific lots may have a small tear in the tubing just above the skin, between the Pod and the point where the cannula enters the body. As of May 20, Insulet reported 24 serious injuries and no deaths associated with this issue.
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Analyst Views on PODD
Wall Street analysts forecast PODD stock price to rise
19 Analyst Rating
18 Buy
1 Hold
0 Sell
Strong Buy
Current: 159.770
Low
316.00
Averages
375.83
High
450.00
Current: 159.770
Low
316.00
Averages
375.83
High
450.00
About PODD
Insulet Corporation is a medical device company. It is primarily engaged in the development, manufacture and sale of its continuous insulin delivery systems for people with insulin-dependent diabetes. The Omnipod System includes the Omnipod 5 Automated Insulin Delivery System (Omnipod 5), the Omnipod DASH Insulin Management System, and the Omnipod Insulin Management System. The Omnipod platform offers continuous insulin delivery that provides various benefits of insulin pump therapy in a way without the need for external tubing required with conventional pumps. The small, lightweight, self-adhesive disposable tubeless Omnipod device (Pod), can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh, or lower back, and delivers insulin into the body through a small flexible tube. It also produces pods for Amgen for use in the Neulasta Onpro kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Insulet Launches Omnipod 5 System in Spain
- Product Launch: Insulet Corporation has launched the Omnipod 5 Automated Insulin Delivery System in Spain, which is indicated for individuals aged two and older with type 1 diabetes, marking a significant milestone in its international expansion.
- Market Coverage: Spain becomes the 26th country where Insulet sells Omnipod products and the 20th market for Omnipod 5, reflecting the company's rapid expansion into 15 countries over the past 18 months.
- Data Management Platform: Insulet is also introducing the Omnipod Discover data management platform in Spain, designed to provide data analytics and reporting for Omnipod 5 users, caregivers, and healthcare providers, enhancing user experience.
- Diabetes Patient Demographics: Spain has over 4.6 million adults with diabetes, including approximately 189,000 individuals with type 1 diabetes and over 18,500 children and adolescents requiring insulin treatment, indicating a broad market demand.
See More
Class Action Lawsuit Announced Against Insulet Corporation
- Class Action Initiation: Rosen Law Firm has announced a class action lawsuit against Insulet Corporation for purchasers of securities between February 21, 2025, and May 26, 2026, indicating potential investor losses during this period.
- Lawsuit Allegations: The lawsuit claims that Insulet's manufacturing controls and procedures were defective, creating a foreseeable risk that its products could violate safety regulations, leading to investor damages.
- Investor Rights Protection: Investors joining the class action can seek compensation without any out-of-pocket fees through a contingency fee arrangement, urging affected investors to act promptly.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has achieved the largest securities class action settlement against a Chinese company, demonstrating its strong capability in protecting investor rights.
See More
Reminder of Securities Fraud Lawsuit for Insulet Corporation Investors
- Lawsuit Deadline: Investors must file a lead plaintiff motion by August 31, 2026, to participate in the securities fraud lawsuit against Insulet Corporation, covering transactions from February 21, 2025, to May 26, 2026, ensuring their legal rights are protected.
- Stock Price Impact: On March 12, 2026, Insulet disclosed a manufacturing issue with Omnipod® 5 Pods, causing its stock to drop by $16.23, or 6.9%, to close at $219.84, resulting in significant losses for investors.
- Ongoing Manufacturing Issues: On May 26, 2026, Insulet announced another voluntary correction for Omnipod® 5 and other products due to potential insulin under-delivery, leading to a further decline of $7.79, or 5.1%, in stock price to $146.01, exacerbating investor losses.
- False Statements Allegations: The lawsuit alleges that Insulet failed to disclose defective manufacturing controls, which misled investors regarding the company's operations and prospects, thereby increasing legal risks associated with the company's statements.
See More
Insulet Corporation Faces Class Action Lawsuit Over Securities Violations
- Class Action Reminder: The Schall Law Firm reminds investors of a class action lawsuit against Insulet Corporation for violations of §§10(b) and 20(a) of the Securities Exchange Act, concerning securities purchased between February 21, 2025, and May 26, 2026, with a deadline for participation set for August 31, 2026.
- False Statements Allegation: The complaint alleges that Insulet made false and misleading statements regarding its manufacturing processes, which were deficient and increased safety violation risks, thereby undermining the quality and market trust in its Pod products.
- Manufacturing Issues Impact: Insulet's March 2026 Medical Device Correction revealed that the number of affected Pod products was greater than previously claimed, leading to significant investor losses once the market learned the truth about the company's operational failures.
- Legal Consultation Opportunity: The Schall Law Firm offers free consultations for affected investors, encouraging them to discuss their rights, highlighting the firm's specialization in securities class action lawsuits and shareholder rights litigation aimed at helping investors recover their losses.
See More
Insulet Corporation Faces Class Action Lawsuit from Shareholders
- Class Action Initiated: A shareholder has filed a class action lawsuit against Insulet Corporation (NASDAQ: PODD) for securities violations between February 21, 2025, and May 26, 2026, alleging that the company and its executives made materially false and misleading statements, resulting in artificially inflated stock prices during the class period.
- Investor Losses: The lawsuit claims that due to the defendants' misrepresentations, investors suffered significant losses when the truth was revealed, highlighting serious concerns regarding the company's business operations and financial stability, which could undermine future investor confidence.
- Participation Requirements: Investors are encouraged to act promptly and submit their applications to join the lawsuit by August 31, 2026, and those wishing to serve as lead plaintiffs must file necessary documents to represent the class effectively.
- Law Firm Background: Bernstein Liebhard LLP has recovered over $3.5 billion for clients since 1993, focusing on representing individual investors and large public and private pension funds, demonstrating extensive experience and a successful track record in class action litigation.
See More
Investigation Launched into Insulet Securities Litigation
- Lawsuit Initiation: Faruqi & Faruqi, LLP is investigating potential claims against Insulet Corporation for investors who purchased securities between February 21, 2025, and May 26, 2026, urging them to apply for lead plaintiff status by the August 31, 2026 deadline.
- Manufacturing Defect Allegations: The lawsuit alleges that Insulet's manufacturing controls and procedures were defective, creating a risk that its products could violate safety regulations and pose risks to patients, rendering the company's public statements during this period materially false and misleading.
- Stock Price Volatility: Following the disclosures of two voluntary Medical Device Corrections on March 12 and May 26, 2026, Insulet's stock price fell by 6.88% and 5.07%, respectively, reflecting investor concerns over the safety of the company's products.
- Investor Rights Protection: Faruqi & Faruqi encourages all investors who purchased Insulet stock during the class period to contact the firm to discuss their legal rights and potential claims, ensuring they can secure their rightful share in any possible recovery.
See More
Insulet Launches Omnipod 5 System in Spain
- Product Launch: Insulet Corporation has launched the Omnipod 5 Automated Insulin Delivery System in Spain, which is indicated for individuals aged two and older with type 1 diabetes, marking a significant milestone in its international expansion.
- Market Coverage: Spain becomes the 26th country where Insulet sells Omnipod products and the 20th market for Omnipod 5, reflecting the company's rapid expansion into 15 countries over the past 18 months.
- Data Management Platform: Insulet is also introducing the Omnipod Discover data management platform in Spain, designed to provide data analytics and reporting for Omnipod 5 users, caregivers, and healthcare providers, enhancing user experience.
- Diabetes Patient Demographics: Spain has over 4.6 million adults with diabetes, including approximately 189,000 individuals with type 1 diabetes and over 18,500 children and adolescents requiring insulin treatment, indicating a broad market demand.
See More
Class Action Lawsuit Announced Against Insulet Corporation
- Class Action Initiation: Rosen Law Firm has announced a class action lawsuit against Insulet Corporation for purchasers of securities between February 21, 2025, and May 26, 2026, indicating potential investor losses during this period.
- Lawsuit Allegations: The lawsuit claims that Insulet's manufacturing controls and procedures were defective, creating a foreseeable risk that its products could violate safety regulations, leading to investor damages.
- Investor Rights Protection: Investors joining the class action can seek compensation without any out-of-pocket fees through a contingency fee arrangement, urging affected investors to act promptly.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has achieved the largest securities class action settlement against a Chinese company, demonstrating its strong capability in protecting investor rights.
See More
Reminder of Securities Fraud Lawsuit for Insulet Corporation Investors
- Lawsuit Deadline: Investors must file a lead plaintiff motion by August 31, 2026, to participate in the securities fraud lawsuit against Insulet Corporation, covering transactions from February 21, 2025, to May 26, 2026, ensuring their legal rights are protected.
- Stock Price Impact: On March 12, 2026, Insulet disclosed a manufacturing issue with Omnipod® 5 Pods, causing its stock to drop by $16.23, or 6.9%, to close at $219.84, resulting in significant losses for investors.
- Ongoing Manufacturing Issues: On May 26, 2026, Insulet announced another voluntary correction for Omnipod® 5 and other products due to potential insulin under-delivery, leading to a further decline of $7.79, or 5.1%, in stock price to $146.01, exacerbating investor losses.
- False Statements Allegations: The lawsuit alleges that Insulet failed to disclose defective manufacturing controls, which misled investors regarding the company's operations and prospects, thereby increasing legal risks associated with the company's statements.
See More
Insulet Corporation Faces Class Action Lawsuit Over Securities Violations
- Class Action Reminder: The Schall Law Firm reminds investors of a class action lawsuit against Insulet Corporation for violations of §§10(b) and 20(a) of the Securities Exchange Act, concerning securities purchased between February 21, 2025, and May 26, 2026, with a deadline for participation set for August 31, 2026.
- False Statements Allegation: The complaint alleges that Insulet made false and misleading statements regarding its manufacturing processes, which were deficient and increased safety violation risks, thereby undermining the quality and market trust in its Pod products.
- Manufacturing Issues Impact: Insulet's March 2026 Medical Device Correction revealed that the number of affected Pod products was greater than previously claimed, leading to significant investor losses once the market learned the truth about the company's operational failures.
- Legal Consultation Opportunity: The Schall Law Firm offers free consultations for affected investors, encouraging them to discuss their rights, highlighting the firm's specialization in securities class action lawsuits and shareholder rights litigation aimed at helping investors recover their losses.
See More
Insulet Corporation Faces Class Action Lawsuit from Shareholders
- Class Action Initiated: A shareholder has filed a class action lawsuit against Insulet Corporation (NASDAQ: PODD) for securities violations between February 21, 2025, and May 26, 2026, alleging that the company and its executives made materially false and misleading statements, resulting in artificially inflated stock prices during the class period.
- Investor Losses: The lawsuit claims that due to the defendants' misrepresentations, investors suffered significant losses when the truth was revealed, highlighting serious concerns regarding the company's business operations and financial stability, which could undermine future investor confidence.
- Participation Requirements: Investors are encouraged to act promptly and submit their applications to join the lawsuit by August 31, 2026, and those wishing to serve as lead plaintiffs must file necessary documents to represent the class effectively.
- Law Firm Background: Bernstein Liebhard LLP has recovered over $3.5 billion for clients since 1993, focusing on representing individual investors and large public and private pension funds, demonstrating extensive experience and a successful track record in class action litigation.
See More
Investigation Launched into Insulet Securities Litigation
- Lawsuit Initiation: Faruqi & Faruqi, LLP is investigating potential claims against Insulet Corporation for investors who purchased securities between February 21, 2025, and May 26, 2026, urging them to apply for lead plaintiff status by the August 31, 2026 deadline.
- Manufacturing Defect Allegations: The lawsuit alleges that Insulet's manufacturing controls and procedures were defective, creating a risk that its products could violate safety regulations and pose risks to patients, rendering the company's public statements during this period materially false and misleading.
- Stock Price Volatility: Following the disclosures of two voluntary Medical Device Corrections on March 12 and May 26, 2026, Insulet's stock price fell by 6.88% and 5.07%, respectively, reflecting investor concerns over the safety of the company's products.
- Investor Rights Protection: Faruqi & Faruqi encourages all investors who purchased Insulet stock during the class period to contact the firm to discuss their legal rights and potential claims, ensuring they can secure their rightful share in any possible recovery.
See More
