The FDA issued a safety alert on November 21, 2019, regarding a Class I recall for Medtronic MiniMed Insulin Pump. A Class 1 recall is the highest urgency recall which indicates that the device poses a high risk of serious injury or death.
Medtronic confirmed 55 cases of the devices failing as of May 32, 2011, including one death attributed to baclofen withdrawal syndrome. The company reached a $35 million settlement in April 2019 with about 500 people who claimed they had been harmed by it.
The FDA also reported that Medtronic had gotten 26,421 error reports and was aware of 2,175 injuries and one death. As of November 2019, there were an estimated 322,000 Medtronic pumps in the U.S. and thousands more internationally. An estimated 180,000 Americans were using the MiniMed 670G pump.
The FDA’s announcement stated that the MiniMed pumps in question were being recalled due to the potential for a broken or missing retainer ring on the pump. The ring is intended to lock the reservoir cartridge of insulin supply into place. If the ring is missing or damaged, the cartridge may not properly lock and if loose, may over deliver or under deliver the insulin dose. Medical device manufacturer, Medtronic has recalled two models of its MiniMed Insulin pumps because of a possibility of life-threatening dosing errors of overdose or underdosage of insulin. People or oved ones of those who were injured by malfunctioning pumps may be considering filing a Medtronic MiniMed Insulin Pump lawsuit.
The recall affects an estimated 322,005 MiniMed 600 series insulin pumps in the U.S. including:
- Model 630G (MMT-1715) manufactured before October 2019
- Model 670G (MMT-1780) manufactured before August 2019
Medtronic Insulin Pump Side Effects
Medtronic’s allegedly defective insulin pumps put diabetic patients at risk of receiving too much or too little insulin, which could have potentially fatal results.
Insulin overdose can cause hypoglycemia, a condition where a person’s blood sugar (glucose) is too low. Symptoms are severe and can include:
- Brain injury
Taking too little insulin can cause hyperglycemia, a condition where a person’s blood sugar is too high. Symptoms can include:
- Loss of consciousness
Hold Medtronic’s Accountable
The November 2019, Medtronic MiniMed Insulin Pump recall is a Class I recall, indicating that it has a high risk for potential harm, however it is not the first recall Medtronic has been forced to issue for their insulin pumps. There is currently one known/reported death as well as 2,175 injuries and 26,421 total complaints about the insulin pumps.
Other recalls have included:
- September 2019 – MiniMed pump with a remote controller recalled over cybersecurity concerns
- June 2019 – MiniMed pumps with certain software versions recalled over hacking concerns
- September 2017 – MiniMed pumps recalled due to potential for a blocked pump membrane which may result in insulin dosing error
- September 2015 – MiniMed 620G and 640G pumps recalled because of malfunctioning drive motor and malfunctioning timer
- September 2014 – MiniMed Paradigm insulin pump recalled after programming errors had resulted in maximum insulin dose being mistakenly delivered
- 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
- 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled due to a manufacturing defect that had resulted in dosing errors
Even though Medtronic’s technology continues to advance, serious risks have continued to occur. These risks may pose threat of severe or permanent injury or even death to the users.
The network of attorneys at Consumer Coalition have vast experience holding big corporations accountable for concealing the true dangers of consumer products. Consumer Coalition intends to hold the drug makers accountable and putting profit before people. Across all areas of practice, they have successfully obtained billions of dollars in verdicts and settlements on behalf of our attorneys' clients.
People may be seeking compensation for:
- Medical costs
- Lost wages
- Future medical costs
- Pain and suffering
If you or a loved one used a Medtronic MiniMed insulin pump and experienced any of these symptoms or injuries, you may be entitled to significant compensation. You are not alone. Join the thousands of others who have been injured due to Medtronic’s carelessness.
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