MEDTRONIC DEFECTIVE INSULIN PUMPS: WHAT TO KNOW
- The FDA has issued an URGENT recall on several insulin pumps manufactured by Medtronic
- Use of these insulin pumps has been linked to Hypoglycemia, Hyperglycemia, Seizures, Ketoacidosis, Diabetic Coma, and Death
- This recall is the latest in a series of major product recalls aimed at Medtronic
- Compensation is available for Medtronic insulin pump victims and their families
- Victims are urged to locate a reputable attorney in order to secure compensation and justice
MEDTRONIC INSULIN PUMPS ARE BEING RECALLED, LINKED TO DEATH
ALERT: If you or a loved one currently uses a Medtronic insulin pump, please review the important safety information below. In 2020, the FDA (U.S. Food & Drug Administration) filed a Class I recall on 600 series MiniMed insulin pumps manufactured by Medtronic.
The recall implicates hundreds of thousands of the company’s MiniMed 630G insulin pumps (used by those 16 and older for management of type 1 diabetes) and MiniMed 670G insulin pumps (used by those 7 and older for management of type 1 diabetes).
Not all recalls are equal. Medtronic’s Class I recall is particularly serious. In fact, a “Class I recall” is the highest-level recall the FDA can implement, essentially meaning a “reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
Covered by this recall are more than 320,000 Medtronic MiniMed insulin pumps, which are used by patients with diabetes to help manage their blood sugar levels.
HOW TO KNOW IF YOU QUALIFY FOR A MINIMED LAWSUIT
You may qualify to file a MiniMed insulin pump lawsuit if you, or someone you know, used one of the following Medtronic devices:
- the MiniMed 630G (all lots before October 2019)
- or the MiniMed 670G (all lots before August 2019)
Furthermore, you or your loved one must have suffered from one of the following injuries:
- Hypoglycemia
- Hyperglycemia
- Seizures
- Diabetic coma
- Ketoacidosis
- Fatal injuries
If you meet these requirements, please contact Cowper Law LLP at 877.529.3707.
WHY IS THERE A RECALL?
At the center of the Medtronic insulin pump recall is one of the device’s key components: the retainer ring. In the case of faulty insulin pumps, the retainer ring is either broken or is completely missing from the device.
A properly functioning retainer ring is essential to a properly functioning insulin pump because it helps lock the insulin cartridge into place.
If the insulin cartridge is not properly secured, it may result in the over or under-delivery of insulin, possibly causing hypoglycemia or hyperglycemia. All told, more than 26,000+ error reports on Medtronic’s devices have been reported, including more than 2,000 injuries and at least one death received by the FDA.
WHAT IS A MINIMED PUMP?
The MiniMed 600 Series Insulin Pump is a medical device used to deliver insulin for use in the management of diabetes. Those with diabetes require insulin to help regulate blood sugar (glucose) levels. The pump attaches to the user’s body through a thin tube called an infusion set. The infusion set is what delivers insulin to the user.
Moreover, an insulin pump replaces the need for frequent injections by delivering fast-acting insulin in a steady fashion. However, Medtronic has produced several insulin pumps that deny users the intended purpose of the device. The harm that they pose is why the recall is currently in effect.
WHO USES THESE PUMPS?
By and large, Medtronic’s insulin pumps are used by those who suffer diabetes in either its Type 1 or Type 2 form.
Type 1 Diabetes Patients: People who have Type 1 diabetes may use the MiniMed insulin pump to deliver insulin to properly manage their diabetes. The Medtronic MiniMed insulin pump 630G may be used by those sixteen years of age and older. And the 670G model may be used by persons seven years of age and older.
Type 2 Diabetes Patients: The MiniMed 630G insulin pump helps recreate the manner in which a healthy pancreas delivers basal insulin to the body for those with Type 2 Diabetes.
HOW ARE THE MEDTRONIC INSULIN PUMPS SUPPOSED TO WORK?
Medtronic insulin pumps are supposed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every few minutes and automating the dosing of insulin. This automated insulin delivery system first received FDA approval in September 2016. At that time, it was heralded as a critical step toward the aim of creating an alleged “artificial pancreas” insulin pump system.
WHICH PUMPS ARE IN THE RECALL?
There are two (2) specific insulin pumps manufactured by Medtronic that are included in the FDA’s Class I Recall:
- The MiniMed 630G manufactured prior to October 2019 (distributed from September 2016 to October 2019)
- The MiniMed 670G manufactured prior to August 2019 (distributed from June 2017 to August 2019)
In total, the recall includes approximately 322,005 insulin pump units in the United States.
THE DANGERS OF A DEFECTIVE PUMP
There are several medical risks to use who use the previously-mentioned insulin pumps from Medtronic, including:
- Hypoglycemia
- Hyperglycemia
- Diabetic seizures
- Diabetic coma
- Ketoacidosis
- Death
WHAT IS HYPOGLYCEMIA?
Hypoglycemia is a condition in which your blood sugar level is lower than normal. Treatment involves quickly stabilizing your blood sugar levels with high-sugar foods or drinks or with medications. Defective Medtronic Insulin pumps may over deliver insulin to users without their being aware of it, resulting in hypoglycemia.
Symptoms of hypoglycemia may include:
- Irregular heartbeat
- Fatigue
- Pale skin
- Sweating
- Tingling or numbness of the lips, tongue, or cheek
WHAT IS HYPERGLYCEMIA?
Different from hypoglycemia, this condition occurs when your blood sugar levels are higher than normal. Medtronic’s insulin pumps can cause hyperglycemia if they under deliver insulin to users. Symptoms of hyperglycemia may slowly over several days or weeks. The longer blood sugar levels stay high, the more serious symptoms may become.
The most important symptoms to be aware of include:
- Frequent urination
- Increased thirst
- Blurred vision
- Feeling weak or unusually tired
WHAT ARE DIABETIC SEIZURES?
A diabetic seizure can occur from too much insulin being injected, or because the user did not eat right after taking insulin, among other things. As with hyperglycemia, a diabetic seizure can be caused by a Medtronic insulin pump if the device OVER-DELIVERS insulin to the user.
Dramatic symptoms, such as uncontrollable body movements and muscle contractions, may occur when a diabetic seizure is taking place. In some cases, the diabetic will be unaware of the movements and may even become unconscious.
Early symptoms of seizures include:
- Sweating
- Bodily shakes
- Hallucinations
- Vision Changes
- Loss of clear verbal function
WHAT IS A DIABETIC COMA?
A diabetic coma takes place when a person with diabetes loses consciousness. This type of Medtronic MiniMed insulin pump injury is considered a medical emergency and can lead to brain damage or death if you do not receive treatment. Frequently, treatment requires intravenous fluids to improve fluid levels throughout the body.
Severe symptoms of diabetic coma include:
- Vomiting
- Difficulty breathing
- Confusion
- Weakness
- Dizziness
WHAT IS KETOACIDOSIS?
Diabetic ketoacidosis (DKA) can occur when your body does not have enough insulin to use glucose for energy. Your body needs insulin to move glucose out of your bloodstream and into your cells, where it is used for energy. Without insulin, your body will use fat for energy. When fat is used for energy, your body produces ketones as a byproduct. Ketones can make you feel ill.
An insulin pump delivers insulin to users through the infusion set. The retainer ring helps make sure the infusion set remains in the proper place to safely supply the insulin. However, defective insulin pumps have retainer rings that are either broken or missing. In turn, this can wreak havoc with the infusion set and, as a consequence, with the proper delivery of insulin to users. As a result, ketoacidosis may occur as a direct result of a faulty insulin pump. Worst of all, DKA (diabetic ketoacidosis) can start to develop in just 5 to 6 hours.
Early warning signs of DKA include:
- Unusual tiredness
- Dry mouth, thirst
- Stomach pain
- Nausea
- Fruity odor to breath
WHAT TO DO IF YOU OR A LOVED ONE HAS EXPERIENCED THESE EFFECTS
If you use the Medtronic MiniMed 600 Series Insulin Pump (either Model 630G or Model 670G), contact the Medtronic Technical Support hotline at 1-877-585-0166.
In November 2019, Medtronic issued a notice to customers advising them to:
- Examine the retainer ring of the insulin pump.
- Stop use of the insulin pump and contact Medtronic for a replacement if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing.
- Continue using the pump if the reservoir locks into place correctly.
- If the pump is dropped accidentally, check the pump and retainer ring for damage and stop use if it’s damaged.
- Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.
WARNING: Both Medtronic and the FDA have advised that in all cases, if you stop using the insulin pump, you should follow your physician’s recommendations and perform manual insulin injections.
IF YOU OR A LOVED ONE SUFFERED AN INJURY AS RESULT OF A DEFECTIVE PUMP, LET US TELL YOUR STORY
If you or a loved one used a Medtronic MiniMed 630G or 670G you suffered injury due to hypoglycemia, hyperglycemia, or another issue related to improper insulin dosage, you may have a claim against the manufacturer. Compensation may be possible in a Medtronic MiniMed insulin pump lawsuit for damages such as:
- Medical expenses
- Lost wages
- Loss of earning capacity
- Out-of-pocket costs
- Pain and suffering
- Wrongful death (if your loved one died as a result of complications associated with excess or insufficient insulin)
Time is of the essence. It is crucial to consult an attorney as soon as possible if you believe you have a claim. An experienced lawyer at Cowper Law can review the details of your case and advise you of your options for pursuing compensation.
MEDTRONIC’S LONG HISTORY OF RECALLS
In September 2021, a Georgia woman filed a new Medtronic infusion pump lawsuit on behalf of her friend, who was severely injured in a car accident in 2011. The plaintiff expressed that, during the time the plaintiff’s pump was being manufactured, the FDA conducted several inspections of Medtronic’s manufacturing and quality control facilities.
In these inspections, FDA personnel discovered a series of significant violations of federal law governing the manufacturing and quality control of Medtronic’s medical devices, such as the SynchroMed II pump. The FDA issued several warnings dealing with these violations.
The FDA also issued at least 19 Class I and II recalls for SynchroMed II pump models during the time the device was on the market, starting in 2004 and continuing through at least 2019. In the October 11, 2019 recall, the FDA noted a risk of the permanent motor stall, such as that which occurred in the plaintiff’s pump.
MEDTRONIC INSULIN PUMP LITIGATION: A TIMELINE
- 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled because of a manufacturing defect that created dosing errors
- July 2013 – MiniMed Paradigm reservoir recalled due to a problem with priming of the pump. The prior month, MiniMed Paradigm infusion sets has been recalled due to similar priming issues
- September 2014 – MiniMed Paradigm insulin pump recalled after programming errors had resulted in maximum insulin dose being mistakenly delivered
- September 2015 – MiniMed 620G and 640G pumps recalled because of malfunctioning drive motor and malfunctioning timer
- September 2016 – Medtronic’s automated insulin delivery system wins FDA approval
- September 2017 – MiniMed pumps recalled due to potential for a blocked pump membrane which may result in insulin dosing error
- 2017 – The FDA approves the MiniMed 630G
- June 2019 – MiniMed pumps with certain software versions recalled over hacking concerns
- September 2019 – MiniMed pump with a remote controller recalled over cybersecurity concerns
- November 2019 – Medtronic warns patients of MiniMed insulin pump safety issue
- November 2019 – Stellato v. Medtronic, Inc. et al is filed in the US District Court for the Middle District of Florida; plaintiff Stellato alleges that his wife with diabetes died hours before husband learned her insulin pump was recalled.
- November 2019 – the U.S. Food and Drug Administration (FDA) announces a Class 1 recall for over 300,000 Medtronic MiniMed 600 series insulin pumps
- February 2020 – Schwartz v. Medtronic Minimed Inc et al is filed in the US District Court for the District of South Carolina; plaintiff Schwartz looks to hold Medtronic accountable for the diabetic coma she suffered after using the Model 630G insulin pump.
- May 2020 – Cowper Law LLP and two other law firms file a group of seven plaintiffs from six U.S. against in the Superior Court of California alleging serious harm after the use of Medtronic’s 600 series insulin pumps.
- January 2022 – FDA issues warning letter to Medtronic, following investigations that demonstrated notable quality control concerns with the manufacturer’s business practices
- March 2022 – Wiggins v. Medtronic Minimed Inc. is filed in the US District Court for the Northern District of Florida; plaintiff alleges that MiniMed 670G insulin pump was defective because the retainer ring failed to sit within the pump properly, causing an over-delivery of insulin.
- April 2022 – Roget v. Medtronic, Inc. et al is filed in the US District Court for the District of Nevada; plaintiff looks to hold Medtronic accountable for the wrongful death of Andre Carl Roget, who had used Medtronic’s MiniMed 630G insulin infusion pump.
- May 2022 – Moze Cowper wins oral argument against Medtronic; Cowper Law LLP is one of three law firms leading the litigation against Medtronic as a result of recalled 600 series Insulin Pumps, earns key legal victory before Judge Berle, in the case Stephen Plum, et al. v. Medtronic Minimed, Inc., et al. , asserting that plaintiffs have the right to communicate and share critical documents with their own physicians prior to a deposition without the involvement of defense counsel.
HIRING THE RIGHT MEDTRONIC INJURY LAWYER TO REPRESENT YOU
Finding the right Medtronic MiniMed insulin pump lawyer for you is an extremely important decision. You should feel confident that your legal representative will not only fight for your compensation but also be there to help you navigate your road to recovery. Let attorney Moze Cowper tell your story.
WHAT A MEDTRONIC INJURY LAWYER WILL DO FOR YOU
There are many advantages to hiring an injury attorney. Your attorney will work hard to assist your claim through the processes of the law, while you focus on what really matters: your recovery and sense of wellbeing. Some of the roles of your attorney include:
- Collecting evidence to support your injury claim
- Establishing liability for your injuries and losses
- Assessing damages in your case and fighting to get you compensation
- Standing up to power and allowing Cowper Law to tell your story
HOW MUCH DOES A MEDTRONIC INJURY LAWYER COST?
Our law firm works on a contingency fee basis. In other words, we do not receive any payment or legal fees until you are justly compensated for your injuries. If you do not receive compensation in the form of a verdict or negotiated settlement, our firm will handle your entire legal bill. To be clear, there is NO cost to you.
MEDTRONIC INSULIN PUMP RECALL: KEY SOURCES
This page’s content was based on the following valuable sources:
- “Medtronic’s Recall of 322,000 MiniMed Insulin Pumps Spurs Lawsuits,” April 27 2022. [DrugWatch]
- “Roget v. Medtronic, Inc. et al, 2:22-cv-00646, No. 1,” April 19 2022. [FDA News]
- “Medtronic’s recall of over 175,000 MiniMed pumps labeled Class II by FDA,” April 8 2022. [MedTechDive]
- “Florida Product Liability Suit Points Finger at Insulin Pump,” March 4 2022. [com]
- “WIGGINS v. MEDTRONIC MINIMED INC,” March 3 2022. [Justia]
- “FDA warning letter cites product safety issues in Medtronic diabetes group,” January 5 2022. [MedTechDive]
- “Medtronic Infusion Pump Malfunctioned and Stalled, Landing Woman in the Hospital,” September 21 2021. [New York Injury Law News]
- “Seven Plaintiffs File Medtronic MiniMed Insulin Pump Lawsuits,” May 23 2020. [Pittsburgh Injury Law News]
- “Evolution of Insulin Delivery Devices: From Syringes, Pens, and Pumps to DIY Artificial Pancreas,” May 14 2020. [SpringerLink]
- “Schwartz v. Medtronic Minimed Inc et al,” February 21 2020. [Justia]
- “FDA says Medtronic MiniMed insulin pump recall is serious,” February 12 2020. [MassDevice]
- “Medtronic warns patients of MiniMed insulin pump safety issue,” November 22 2019. [MassDevice]
- “Orlando woman with diabetes dies hours before husband learned her insulin pump was recalled,” November 19 2019. [Orlando Sentinel]
- “Stellato v. Medtronic, Inc. et al,” November 14 2019. [Justia]
- “Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing,” November 2019. [FDA]
- “Insulin Pumps and Diabetic Ketoacidosis (DKA),” June 2013 [UW Medicine]