Insulin Pump Lawsuit | 2026 Latest Updates

The FDA has issued Class I recalls and corrections for insulin pumps from Medtronic MiniMed, Tandem and Insulet. Reports describe under-delivery of insulin, stopped delivery and high blood glucose. Insulet announced a second correction of about 7 million Omnipod 5, Dash and Eros pods in May 2026. No MDL exists for insulin pumps. The only lawsuit, an investor suit against Medtronic, was dismissed with prejudice on September 30, 2025. People who use pods from affected lots should not use them and should contact the maker.

Latest Insulin Pump Lawsuit Updates

May 26, 2026: Insulet Announces Second Omnipod 5 Correction

On May 26, 2026, Insulet announced a voluntary correction of specific lots of Omnipod 5, Dash and Eros pods. Drug Delivery Business reported a scope of about 7 million pods, about 60% consumed or expired [1]. Insulet reports 24 global serious adverse events tied to high blood glucose, including hospitalization and DKA, and no deaths. It says this issue is separate from the March recall.

April 30, 2026: FDA Corrects Injury Count for Omnipod 5

On April 30, 2026, the FDA updated its Omnipod 5 recall communication to correct the number of serious injuries reported by Insulet [2]. As of April 17, Insulet had reported 29 serious injuries and no deaths. The update was based on new information from the firm and also clarifies that expired affected lots are included in the correction. No additional lots were added.

April 29, 2026: FDA Confirms Class I Recall

On April 29, 2026, the FDA updated its Omnipod 5 communication to include expired lots. The FDA also confirmed that the issue has been classified as a Class I recall, the most serious type.

April 10, 2026: Insulet Expands Omnipod 5 Lot List

On April 10, 2026, Insulet sent affected customers an updated letter. It expanded the list of affected Omnipod 5 lots to include Pods that have expired. The letter also clarified that the Pod defect may not be detectable by users.

March 18, 2026: FDA Issues Omnipod 5 Early Alert

On March 18, 2026, the FDA issued an Early Alert about the Omnipod 5 Pod issue. The agency used the alert to notify the public of a potentially high-risk device issue.

March 12, 2026: Insulet Warns of Omnipod 5 Tubing Tear

On March 12, 2026, Insulet sent all affected customers a letter about Omnipod 5 Pods from certain lots. The letter said the Pods may have a small tear in the internal tubing that delivers insulin. Insulet announced a voluntary correction in the United States. The tear can under-deliver insulin, so users may have high blood glucose levels.

September 30, 2025: Court Dismisses Medtronic Investor Class Action

On September 30, 2025, Judge Laura M. Provinzino of the U.S. District Court for the District of Minnesota dismissed with prejudice an investor securities class action against Medtronic over its insulin pump business [3]. Provinzino dismissed the investors’ misrepresentation and scheme claims. Because this was the investors’ second chance at amending their complaint, the suit was dismissed with prejudice. It is not a patient injury case.

August 12, 2025: FDA Posts Tandem Pump Correction

On August 12, 2025, the FDA posted Tandem Diabetes Care’s voluntary correction for select t:slim X2 pumps [4]. Tandem’s release is dated August 7, 2025, and customer notices went out between July 22 and 24, 2025. Tandem cited 700 confirmed adverse events and 59 reported injuries. No deaths have been reported. It defined an adverse event as a confirmed high blood sugar and/or an event requiring medical intervention.

March 28, 2024: Judge Dismisses First Investor Complaint

On March 28, 2024, Judge Katherine Menendez of the same Minnesota federal court dismissed the investors’ first complaint against Medtronic. The complaint concerned statements about its MiniMed insulin pumps [5]. Bloomberg Law reported that the investors failed to state claims for security fraud tied to statements about allegedly flawed MiniMed models. The investors later filed an amended complaint, which was dismissed in 2025.

February 13, 2020: Class I Recall of MiniMed 600 Series Pumps

On February 13, 2020, the FDA announced a Class I recall of Medtronic MiniMed 600 series pumps (630G and 670G) for a missing or broken retainer ring, according to the American Association of Clinical Endocrinology [6]. The recall covers 322,005 devices in the U.S. The firm has received 26,421 complaints and is aware of 2,175 injuries and 1 death. Class I is the FDA’s most serious recall type.

November 21, 2019: Medtronic Notifies MiniMed Customers

On November 21, 2019, Medtronic notified affected MiniMed 630G and 670G customers about the retainer ring problem. Medtronic advised customers to stop use of the pump if the reservoir does not lock into the pump. Customers should also stop use if the retainer ring is loose, damaged or missing, and contact Medtronic for a replacement pump.

November 25, 2008: FDA Posts Animas 2020 Battery Cap Recall

On November 25, 2008, the FDA posted the Class 1 recall of Animas 2020 insulin pump battery caps (recall number Z-0292-2009) [7]. The firm, Animas Corporation, had initiated the recall on August 4, 2008. The recall was terminated on February 4, 2010. The FDA record says a battery cap failure may stop the device from administering insulin therapy. That may result in hyperglycemia.

May 5, 2008: Report on FDA Review of Insulin Pump Use

On May 5, 2008, the Seattle Times ran an AP report on an FDA review of young people’s pump use from 1996 to 2005 [8]. It found 13 deaths and more than 1,500 injuries connected with the pumps.

What Is an Insulin Pump?

The FDA says insulin pumps manage diabetes, where blood glucose levels are too high. The pumps provide doses of the hormone insulin under the skin (subcutaneously) [9]. The FDA describes the Omnipod as intended for the subcutaneous delivery of insulin, at set and variable rates. It is meant for the management of diabetes mellitus in persons requiring insulin.

Who May Be Affected?

Users of Omnipod 5 Pods from affected lots, including expired lots, may be affected. Users of t:slim X2 pumps on the serial-number list in the August 2025 correction may also be affected. So may users of Medtronic MiniMed 630G pumps sold from September 2016 to October 2019. The same goes for 670G pumps sold from June 2017 to August 2019. These pumps are used to manage Type 1 diabetes. Owning an affected pump does not show that it caused harm in your case. Only an individual legal review can say whether you may have a claim, so talk to a lawyer.

Reported Injuries or Damages

Company and regulator reports describe harm from insulin pump problems. These are reports, not court findings. Each pump has a different reported problem:

• Omnipod 5: under-delivery of insulin and high blood glucose, which can lead to diabetic ketoacidosis.
• t:slim X2: stopped insulin delivery and hyperglycemia.
• MiniMed: under- or over-delivery of insulin.

The only lawsuit allegations come from Medtronic investors, who claimed financial losses. They did not allege patient injuries, and the court rejected their claims.

Recall and Regulatory Background

The FDA has identified three recent insulin pump actions as Class I, the most serious type. A recall does not prove liability. Consumers can contact Tandem at 1-877-801-6901 and Insulet at 1-800-641-2049. No MDL exists for insulin pumps, per the Judicial Panel on Multidistrict Litigation [10]. For more on the Omnipod correction, read our Omnipod recall lawsuit page.

Evidence to Preserve

Keep records that show which pump you used and what happened. These items matter:

• Pump model, serial number and lot number, found on the Pod tray lid, box or Pod.
• The notice or letter you received from the maker.
• Purchase and replacement records for the pump or pods.
• Photographs of the device, its alarms and any error messages, such as Malfunction 16.
• Glucose meter and CGM readings from the time of the problem.
• Medical records and bills linked to the event.
• Communications with the manufacturer about the problem.

Filing Deadlines

State law sets filing deadlines. They vary with where you live and when the injury and its cause were discovered or diagnosed. Letting a filing date pass can end a claim for good. So anyone who used an affected pump should speak with a lawyer promptly.

Frequently Asked Questions

What Should I Do If My Tandem Pump Shows Malfunction 16?

If a t:slim X2 shows a Malfunction 16 alert, press Silence Alarm and contact Tandem for a replacement pump. Switch to a backup method of insulin delivery as your physician directs. Tandem support is also at Techsupport@tandemdiabetes.com.

What Are the Current Recalls for Medtronic Diabetes Devices?

The current Medtronic diabetes device recall covers MiniMed 630G and 670G pumps. Contact Medtronic Technical Support at (877) 585-0166 for a replacement. In the meantime, follow your doctor’s advice on manual insulin injections.

What Does the Research Say About Insulin Pump Safety?

The research on insulin pump safety includes an FDA review of use by young people. It found that devices at times malfunctioned. At other times, users were careless or took risks. The researchers called for more study to address safety concerns.

How Can I Tell If an Omnipod Pod Is Affected?

An Omnipod user may notice wetness on the skin or pod adhesive or smell insulin from an affected pod. Some cases are difficult to detect and may go unnoticed. The issue does not affect integrated CGM readings.

What Is Tandem Doing About the Speaker Problem in Its Pumps?

Tandem is addressing the speaker problem in its pumps with a software update. Tandem Diabetes Care will release it to enhance early detection of speaker failure and introduce persistent vibration alerts. Tandem will notify affected pump users when it becomes available.

Are Omnipod Pods Outside the Affected Lots Safe to Use?

Omnipod pods outside the affected lots remain safe to use, according to Insulet. Affected users can obtain replacement pods at no cost. Insulet says its lot list identifies the affected pods.

References

1. https://www.drugdeliverybusiness.com/insulet-another-omnipod-5-recall-dash-eros/
2. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-certain-omnipod-5-pods
3. https://www.drugdeliverybusiness.com/court-sides-medtronic-insulin-pump-class-action/
4. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-tslim-x2-insulin-pumps
5. https://news.bloomberglaw.com/litigation/medtronic-shakes-investor-claims-over-insulin-pump-problems
6. https://pro.aace.com/recent-news-and-updates/recall-medtronic-minimed-insulin-pumps-recalled-incorrect-insulin-dosing
7. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73593
8. https://www.seattletimes.com/seattle-news/health/insulin-pumps-linked-to-teen-deaths/
9. https://www.fda.gov/medical-devices/medical-device-recalls/insulin-pump-correction-tandem-diabetes-care-issues-correction-certain-tslim-x2-insulin-pumps-due
10. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-October-1-2026.pdf