Insulin Pump Injury

Injured by a defective insulin pump?

Recent FDA recalls and safety actions have affected some major insulin pump manufacturers, including Class I recalls of Medtronic MiniMed, Tandem Mobi, and Insulet Omnipod 5, as well as a Class II recall and an FDA warning letter issued to Beta Bionics regarding its iLet system.

If a documented pump malfunction caused serious injury, you may be entitled to compensation.

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A case specialist will follow up within two business days.
Strict filing deadlines may apply; do not wait.

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Who Qualifies

We focus on serious injuries from device failures.

Not all pump issues rise to the level of a legal claim. To pursue a claim, there must be an injury caused by a device failure, supported by documentation.

You may qualify if

You were hospitalized due to a pump malfunction.
You experienced diabetic ketoacidosis (DKA), severe hypoglycemia, or coma.
You have documentation of a device malfunction, a pump alert, an error code, or a recall.
You have medical records documenting the injury.
The injury happened within your state’s filing deadline.

You may not qualify if

The pump issue resulted from user error, not a defect.
The reported injury does meet the internal criteria for this matter.
You have no medical documentation of the event.
You are already represented by another attorney for this matter.
The statute of limitations has already expired.

FDA Actions, 2024–2026

Multiple Class I recalls have been issued.

Class I is the FDA's most serious recall, a reasonable probability of serious injury or death.

The FDA has issued multiple Class I and II recalls, as well as warnings, against major insulin pump manufacturers in recent months, indicating a reasonable probability of serious injury or death.

FDA Class I · 2026

Insulet Omnipod 5 Pods

In March 2026, Insulet voluntarily recalled certain Omnipod 5 pods after identifying a manufacturing defect that could cause insulin to leak into the pod rather than be delivered to the body. Under-delivery can lead to high blood glucose and, in severe cases, diabetic ketoacidosis (DKA).

The FDA designated this a Class I recall on April 17, 2026, with 476 serious injuries reported.

FDA recall page — insulin-pump-recall-insulet-removes-certain-omnipod-5-pods FDA safety alert — insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us FDA Class I device recall record (Omnipod 5 ACE Pump)

FDA Class I · 2025

Tandem Mobi Insulin Pumps

In November 2025, Tandem issued an urgent correction for over 17,700 Mobi pumps. A software defect could cause the pump to incorrectly detect a motor failure and stop delivering insulin, leading to hyperglycemia.

The FDA classified this as a Class I recall on November 5, 2025.

FDA recall page — insulin-pump-correction-tandem-diabetes-care-issues-correction-tandem-mobi-insulin-pumps

FDA Class I · 2024

Medtronic MiniMed 600 & 700 Series

In October 2024, the FDA issued a Class I recall for Medtronic MiniMed 600 and 700 series pumps (models 630G, 670G, 770G, and 780G) due to wiring damage from physical impacts, which could cause shorter-than-expected battery life and unexpected interruptions in insulin delivery. Medtronic received 170 reports of hyperglycemia and 11 reports of DKA between January 2023 and September 2024.

FDA Class I designation announced in October 2024. Over 785,000 units affected.

FDA recall page — insulin-pump-recall-medtronic-notifies-users-minimed-600-and-700-series FDA safety alert — voluntary-recall-notifying-medtronic-insulin-pump-users

FDA Class II · 2025

Beta Bionics iLet

In August 2025, Beta Bionics initiated a medical device correction for the iLet ACE Pump and Dosing Decision Software over a cybersecurity vulnerability in the device's Limited Access ("lock") mode. The vulnerability could allow unauthorized pump control, including stopping insulin delivery or triggering unauthorized meal announcements, potentially causing severe hypoglycemia. The FDA posted this as a Class II recall in April 2026. Separately, in January 2026, the FDA issued a warning letter to Beta Bionics, citing inadequate complaint handling and failure to report device malfunctions, including at least one case of DKA.

Class II recall posted April 10, 2026. Warning letter issued January 28, 2026.

FDA device recall record — id=218989 FDA warning letter — beta-bionics-inc-717927-01282026

Common Injuries

Injuries that may support a legal claim

When a pump fails to deliver the right dose, too much, too little, or not at all, the consequences can be severe and sometimes fatal.

Diabetic Ketoacidosis (DKA)

A life-threatening complication of prolonged high blood glucose, often from insulin under-delivery.

Severe Hypoglycemia

Dangerously low blood sugar from insulin over-delivery, which can lead to seizures or coma.

Hospitalization & ER Visits

Many pump malfunctions result in emergency room admission and extended hospital stays.

Coma or Brain Injury

Severe glucose imbalances can cause loss of consciousness and lasting neurological damage.

Cardiac Complications

Acute glycemic events have been linked to heart rhythm disturbances and cardiac injury.

How It Works

What happens after you submit.

No upfront cost. No obligation. Free review of whether your situation fits the criteria.

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A specialist will reach out within two business days to learn more about your situation and answer your questions.

Review Your Options

If your case qualifies, we connect you with an experienced attorney. No fee unless we recover.