FDA Expands Recall of Medtronic MiniMed Insulin Pumps
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Why Are the Medtronic MiniMed Insulin Pumps Being Recalled?

The FDA issued a Class 1 recall of the Medtronic MiniMed insulin pump products MinMed 630G and the MiniMed 670G after the device was linked to 26,421 consumer complaints, 2,175 injuries and one death. The announcement comes after the regulatory agency’s discovery that the devices were incorrectly dosing insulin which could cause serious adverse effects that were not included on the device’s label. The defect stems from a missing or broken retainer ring, which helps to lock the insulin cartridge in place.

Is the MiniMed Insulin Pump Dangerous?

Due to the defective design, an unsuspecting user may receive too much or too little insulin which could cause serious, life-threatening affects. An excess of distributed insulin can result in hypoglycemia, a condition in which your blood sugar level is lower than normal. Potential complications of hypoglycemia include:

  • Irregular heartbeat
  • Fatigue
  • Pale skin or sweating
  • Tingling or numbness of the tongue, lips, or cheek

As hypoglycemia worsens, signs and symptoms can include:

  • Confusions and disorientation
  • Blurred vision
  • Seizures
  • Loss of consciousness, such as a diabetic coma.

Conversely, having insufficient dosing of insulin can lead to hyperglycemia, otherwise known as high blood sugar. Hyperglycemia can cause problems commonly associated with uncontrolled diabetes, like:

  • Increased thirst and/or hunger
  • Blurred vision
  • Frequent urination
  • Headache
  • Fatigue
  • Weight loss
  • Slow-healing cuts or sores

In extreme cases, hyperglycemia can lead to a serious condition known as ketoacidosis with complications including:

  • Vomiting and dehydration
  • Labored breathing or hyperventilation
  • Coma

 

What is a Medtronic MiniMed Insulin Pump?

The MiniMed 600 series is a line of medical devices from manufacturer, Medtronic, meant to help diabetics track their insulin levels and maintain healthy amounts of insulin. The insulin pump is a small, computerized device attached to the user’s body via a thin tube under the skin that delivers rapid-acting insulin to continuously manage normal blood sugar levels.

The pumps release insulin similar to the way the body naturally would through a steady stream throughout the day as well as an extra dose around meals. The action of rapid-acting insulin is more calculated and reproducible than long-acting insulin causing easier absorption. The innovative technology was a blessing for those managing type 1 diabetes and many people with type 2 as it replaced the need for frequent injections.

 

Which Medtronic Pumps Are Being Recalled?

Th two insulin pump products recalled are MiniMed 630G devices and MiniMed 670G. The FDA has identified the recall of the 463,464 MiniMed 600 series insulin pumps as a Class 1 recall, the most serious type of recall. A Class 1 recall is classified only for devices that use may cause serious injuries or death. The MiniMed 630G pumps were distributed between September 2016 and February, while the MiniMed 670G had a longer time span from May 2015 to December 2020.

 

What Is the Difference Between the MiniMed Systems?

Medtronic MiniMed has a 40-year history and touts being the first to market the integrated pump and continuous glucose monitoring system. The medical device manufacturing giant has produced four insulin pump models: Paradigmâ„¢ series, the MiniMedâ„¢ 630G, MiniMedâ„¢ 670G, or MiniMedâ„¢ 770G. With the MiniMed 630G and MiniMed 770G serving as an upgrade to new customers. The FDA first approved the MiniMed 630G in August 2016, marketing the device as a complete makeover for insulin pumps with a new design and colored screens. Soon followed the 670G model in 2017 with a hybrid closed loop system consisting of a pump and an infusion catheter allowing for continuous glucose monitoring.

As stated in the FDA’s recall, people who have Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The Medtronic MiniMed insulin pump 630G may be used by persons sixteen years of age and older. Whereas the 670G model may be used by persons seven years of age and older.

 

What Should I Do If My Medical Device Was Recalled?

In November 2019, Medtronic issued a patient safety alert letter warning of possible defects of the retainer ring, a piece of pump hardware used to help lock the insulin cartridge in place, could break or be missing. The company urged users to check the rings on their device and discontinue use if broken.

Just three months later, the FDA announced its full recall of the MiniMed 600 series insulin pumps. The FDA also reported that Medtronic had gotten 26,421 error reports and was aware of 2,175 injuries and one death.

This year on October 5, 2021, Medtronic updated its recall with information that Medtronic will replace any insulin pumps that has a clear retainer ring with one that has the updated black retainer ring. The FDA is advising customers to:

  1. Determine if you have a clear retainer ring. This can be done by clicking here and entering the serial number of your pump.
  2. Examining the retainer ring of the pump.
  3. If the retainer ring is loose, damaged, or missing, stop use of the pump immediately and contact Medtronics. If you stop using the pump, you should follow your doctor’s recommendations for further assistance.
  4. If your reservoir locks in place, continue the use of your pump, but verify that the reservoir is locked correctly at every set change.

 

How can Meyers & Flowers Help?

If you or a loved one believe you have been harmed by a Medtronic MiniMed 600 Series Insulin Pump, contact our experienced product liability team to get the help you deserve. Our cases are handled on a contingency fee basis, so there is no cost to you unless we award you compensation for your injuries.

Our team at Meyers & Flowers has experience handling and winning an array of medical device litigations. With more than two decades helping those injured by negligent companies, our track record of large resolutions for victims of dangerous drugs is a testament to the representation you will receive. Contact us today for a free case evaluation at (630) 232-6333, [email protected], or on our website.