Modern insulin pumps are automated systems designed to mimic natural insulin production, and many integrate with continuous glucose monitors into hybrid closed-loop systems.
When that device fails, the consequences can unfold within hours: diabetic ketoacidosis, seizures, coma, or death.
Recent recalls and hundreds of reported injuries have brought national attention to defects in popular insulin pump systems. The short answer to the question in the headline is Yes.
Defective insulin pumps can cause diabetic ketoacidosis, coma, and death, and when a device failure causes these outcomes, the manufacturer can potentially be held legally responsible.
Prior results do not guarantee a similar outcome.
What Happens When an Insulin Pump Stops Working Properly
Pump users typically rely on rapid-acting insulin delivered continuously in small amounts, rather than the long-acting “background” insulin used in injection regimens. If delivery stops or slows, there’s no safety net, and the body can run out of insulin quickly.
Under-delivery causes blood glucose to climb. Without insulin to help cells absorb glucose, sugar accumulates, and the body begins breaking down fat for fuel, producing acidic compounds called ketones.
When ketones build up faster than the body can clear them, the blood becomes increasingly acidic. This is diabetic ketoacidosis (DKA), a medical emergency.
Early symptoms include excessive thirst, frequent urination, nausea, vomiting, and abdominal pain; as it progresses, breathing becomes rapid, confusion sets in, and without treatment the person can slip into a coma.
Over-delivery is just as dangerous in the other direction. A software glitch, hardware malfunction, or sensor error can cause blood glucose to plummet. Severe hypoglycemia starves the brain of its primary fuel. Early signs include shakiness, sweating, confusion, and irritability, progressing to seizures, loss of consciousness, cardiac arrhythmia, or coma.
Prolonged severe hypoglycemia can cause permanent brain damage.
Both failure modes are especially dangerous overnight, when a device that fails silently, without triggering an alarm, can leave someone in crisis before they or anyone else notices.
How Fast Can This happen?
One published clinical review estimated that after insulin delivery is interrupted, blood glucose can reach roughly 300 mg/dL in an average of about 6 hours and 400 mg/dL in about 8 to 9 hours, with moderate ketone buildup typically following within another few hours and more severe ketonemia within half a day or so.
Individual timelines vary based on the person, their insulin sensitivity, and how much insulin was on board when delivery stopped, but the pattern is consistent: this is a fast-moving emergency, not a slow one.
For context on how serious DKA is as a category, independent of any device issue: a CDC analysis of national hospital data found that DKA hospitalization rates among Americans with diabetes rose 54.9% between 2009 and 2014, from 19.5 to 30.2 per 1,000 people with diabetes, even as the in-hospital death rate for DKA patients fell from 1.1% to 0.4% over the full 2000–2014 period as treatment improved.
It’s also worth being direct about something research shows and a plaintiff-side article can be tempted to gloss over: not every DKA event in a pump user traces back to a device defect.
Recent Recalls Show the Scope of the Problem
A Class I recall is the FDA’s most serious classification, reserved for situations where there’s a reasonable probability that using a product will cause serious injury or death. Several major insulin pump systems have faced recalls at this level.
Omnipod 5 and related pods. In March 2026, Insulet Corporation initiated a Medical Device Correction for specific lots of Omnipod 5 pods after identifying a manufacturing defect: a small tear in the internal tubing that delivers insulin. If insulin leaks inside the pod instead of reaching the body, the pump’s display can still appear normal, with no alarm and no error message, while blood glucose climbs unchecked.
The FDA classified this as a Class I recall. In May 2026, the correction expanded to cover certain Omnipod 5, Omnipod DASH, and original Omnipod (Eros) pods for a related but distinct defect: a tear in the external tubing (cannula) just above the skin, which can also cause insulin to leak before reaching the body.
Tandem t:slim X2 and its companion app. In March 2024, Tandem Diabetes Care recalled version 2.7 of its t:connect iOS app after a software glitch caused the app to repeatedly crash and relaunch, draining the pump’s battery and, in some cases, causing it to shut down and suspend insulin delivery.
The FDA classified this as a Class I recall; as of mid-April 2024, Tandem had reported 224 injuries and no deaths. Separately, in 2025, Tandem identified a wiring issue affecting certain pump speakers that could cause the device to stop delivering insulin and lose communication with its continuous glucose monitor; the company reported roughly 700 adverse event reports and 59 injuries connected to that issue, again with no reported deaths.
Medtronic MiniMed 600 and 700 series. In October 2024, Medtronic issued a Class I recall covering more than 785,000 MiniMed 630G, 670G, 770G, and 780G pumps after finding that a drop, bump, or other physical impact, even a single one, could damage internal electrical components and shorten battery life without the user knowing.
That could cause the pump to stop delivering insulin sooner than expected, sometimes before the low-battery warning gave enough notice to react. From January 2023 through September 2024, Medtronic reported 170 cases of hyperglycemia above 400 mg/dL and 11 cases of DKA it linked to the issue, with no deaths reported.
How Insulin Pump Failures Get Reported and Tracked
Manufacturers, healthcare facilities, and in some cases device users are required to report certain adverse events to the FDA:
Manufacturers generally must report a death or serious injury within 30 days of learning a device may have caused or contributed to it, or within 5 days for events requiring immediate action to prevent public harm.
Hospitals and other user facilities must report device-related deaths to both the FDA and the manufacturer within 10 working days.
These reports feed the FDA’s MAUDE database, which helps identify patterns that can lead to recalls or other regulatory action.
Can You Sue for a Defective Insulin Pump?
Yes. When a defective insulin pump causes DKA, coma, permanent injury, or death, the injured person or their family can generally pursue a product liability claim against the manufacturer and potentially other parties in the distribution chain, and in fatal cases, a wrongful death claim.
New York applies strict liability to defective products, meaning you don’t have to prove the manufacturer was negligent in the traditional sense, only that the product was defective and that the defect caused the injury.
These claims generally fall into a few categories, often pursued together:
Design defect. The pump or its software was inherently unsafe, for example an alarm system without adequate redundancy that made silent failures foreseeable, a user interface that made dosing errors too easy, or a pump-CGM integration with predictable failure modes the manufacturer should have designed around.
Manufacturing defect. A specific device or batch deviated from the intended design, such as the internal tubing tears described above. The design itself may have been sound, but something went wrong during production or quality control.
Failure to warn. The manufacturer knew about a failure mode that could cause DKA or severe hypoglycemia but didn’t clearly warn users, or its warning labels understated a known risk’s severity.
Negligence. This looks at the manufacturer’s overall conduct: whether it ignored adverse event reports, failed to investigate complaints, continued selling devices it knew were dangerous, or delayed a recall despite known problems.
How New York Law Applies
New York follows strict product liability principles: you must show the product was defective, that the defect existed when it left the manufacturer’s control, and that the defect caused the injury or death. Potential defendants can include the pump manufacturer, the CGM manufacturer if the systems are integrated, and potentially distributors, depending on the facts.
Deadlines:
Product liability, generally three years from the date of injury under CPLR 214(5).
Wrongful death, generally two years from the date of death under EPTL 5-4.1.
These deadlines can be affected by discovery rules and other case-specific factors, but the core point is the same: waiting too long can permanently destroy your legal rights.
Damages can include:
Medical bills, hospitalization costs, and lost earnings
Funeral expenses in a wrongful death case
A survival action for the injured person’s conscious pain and suffering, if they survived for some period before death
Loss of support, services, and guidance to statutory beneficiaries in a wrongful death claim
Punitive damages, in cases involving evidence of reckless or particularly egregious manufacturer conduct, such as concealing a known defect or ignoring repeated safety warnings.
Who Might Have a Case
You or a family member was hospitalized for DKA, hyperosmolar hyperglycemic state, or severe hypoglycemia, and medical records or device data connect the episode to pump failure
The event involved diabetic coma, whether or not the person recovered
A loved one died and medical records, autopsy findings, or device data show a severe glycemic event tied to pump or sensor malfunction
You received a recall notice or medical device correction letter for your specific pump or CGM, especially a Class I recall, and experienced a serious adverse event with that device
Your pump displayed error messages, failed to alarm when it should have, or showed erratic delivery in downloaded data logs around the time of the injury
What Evidence Matters in These Cases
Medical records, including emergency and hospital admission notes, ICU documentation, blood glucose and ketone levels, arterial blood gas results, and full treatment records
Device data, since modern pumps and CGMs store detailed logs of insulin delivery, glucose readings, alarms, and system errors. This data can be overwritten or lost, so downloading it promptly is critical
Recall notices and FDA safety communications tied to your specific pump model and lot number
Adverse event reports showing that your experience wasn’t isolated, which supports the argument that the defect was foreseeable
Expert testimony is almost always required: medical experts to connect the device failure to the injury, engineering experts to analyze the device and identify the defect, and regulatory experts to address whether FDA requirements were violated.
Why These Cases Differ From Medical Malpractice
A defective insulin pump case isn’t a medical malpractice claim against a doctor or hospital; it targets the manufacturers and distributors of the device itself.
Sometimes both types of claims exist in the same situation, for example if a doctor was negligent in selecting an inappropriate device while the device itself was also defective, but the legal theories, defendants, deadlines, and proof requirements differ.
A thorough legal evaluation can identify all potential sources of liability so a claim is brought against the right parties, rather than families focusing solely on providers who had no reason to suspect the device itself was dangerous.
Frequently Asked Questions
My pump was part of a recall, but I haven’t had a serious health event yet. Do I have a claim?
Generally not on its own. A recall is important evidence that the manufacturer identified a real defect, but a product liability claim typically requires an actual injury connected to that defect. If you’re using a recalled device, the more immediate priority is following the manufacturer’s correction instructions and talking with your care team; if you do experience a serious glycemic event later, that recall history becomes relevant evidence.
What if my pump didn’t display any error before the emergency?
That’s common with these specific defects and doesn’t rule out a claim. Several of the documented failures, including the Omnipod tubing tears, can cause silent under-delivery with no alarm or error message. Downloaded device data, rather than what the screen showed at the time, is often what actually reveals the malfunction.
Can I bring a claim if my loved one had other health complications from diabetes before the pump failure?
Possibly. Having underlying diabetes-related health issues doesn’t automatically prevent a claim, but it can make proving that the device defect was a substantial cause of the specific injury or death more complex. This is exactly the kind of question expert testimony is used to address.
Is there a difference between a Class I recall and a “correction”?
Yes, and they’re not opposites. Class I refers to the FDA’s severity classification (the most serious). A “correction” describes the type of action taken, meaning the device stays in use with an update, fix, or new instructions rather than being physically removed from the market. Several of the recalls discussed above were both Class I and structured as corrections.
How soon should I talk to an attorney after a serious insulin pump-related injury or death?
As soon as possible. Device data can be overwritten, and the sooner it’s preserved, the stronger the evidence. New York’s deadlines are strict, and these cases require substantial investigation and expert work that takes time to build properly.
Summing It Up
Defective insulin pumps can and do cause diabetic ketoacidosis, diabetic coma, and death, and recent Class I recalls of major pump systems confirm that serious design and manufacturing defects have put users at real risk.
Porter Law Group represents New York families in catastrophic injury, medical malpractice, and product liability cases, including those involving defective medical devices.
If you or a loved one has been affected by a defective insulin pump or continuous glucose monitor, call 833-PORTER9, email info@porterlawteam.com, or reach us through our contact page for a free, confidential consultation.
Prior results do not guarantee a similar outcome.
This article is for informational and educational purposes only. It is not a substitute for medical advice from a qualified healthcare provider or legal advice based on your specific circumstances.
