The medical device giant Medtronic recently issued a recall which affects hundreds of thousands of diabetes patients. The company has recalled its Minimed insulin pumps due to a potentially deadly situation. Nearly half a million units were involved in the recall which was given the most serious rating of Class I, which is assigned when the safety issue can possibly cause death. There have been numerous reports of injuries associated with this problem and even possible death. As always, if you or a loved one has suffered an injury from this defective insulin pump, you should contact a product liability lawyer to learn your legal rights.
Diabetics rely on insulin pumps to help them manage their conditions. These pumps are used to deliver insulin to the body and maintain the proper blood glucose levels. When these pumps work correctly, they are a large advance to helping diabetics live a normal every day while managing their condition. However, when the device malfunctions, it can have dramatic consequences due to how vital insulin levels are for diabetics.
The Medtronic 600 Series Pump Recall
In November 2019, Medtronic issued a communication alerting patients to the possible issue with these insulin pumps. The specific issue related to the MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) insulin pumps. These pumps were initially approved by the FDA in 2016 and were hailed as a significant advance in the field. Some have even gone so far as to call this class of Medtronic pumps an artificial pancreas for the manner in which it can help control blood glucose levels.
Here, the problem was that the insulin pump was either missing a retainer ring or had a broken one. This part is critical in locking the insulin cartridge in place. It is necessary for this cartridge to be properly in place in order for the correct amount of insulin to be given.
The issue that is caused can result in the delivery of too much or too little insulin. Incorrect dosage is a serious problem for diabetics who rely on the proper dose of insulin on a daily basis. While the likely side effect from incorrect dosage is injury, it could even lead to death in some circumstances. This is a problem for those with Type 1 diabetes.
The Consequences of the Medtronic Insulin Pump Product Defect
The incorrect dosage can result in Hypoglycemia or hyperglycemia. These conditions can cause patients to become dizzy or confused. When it is serious, this can lead to a loss of consciousness or seizures. In a worst-case scenario, it can cause death, and it apparently did for one patient. In addition to the one death that was reported, there were also reports of 2,175 injuries that resulted from the safety issue. Medtronic received over 26,000 complaints of a broken or missing retainer ring that prompted the safety communication and the recall.
With the initial safety notice, patients were advised to check their existing pump system to see if there was an issue with the retainer ring. The key issue that patients were checking for was to see if the reservoir pump locked into place. Units that locked into place correctly were acceptable for continued use. However, if the ring was broken or did not lock into place, customers were able to exchange the pump for a new one. Even if the insulin pump passed the initial safety check, patients were urged to continuously check their pump to see if the problem has developed. Any time they drop their pump, patients should check the retainer ring to see if it is damaged.
In February 2020, the FDA broadened this to a recall which affected all of these pumps manufactured before a certain date. All Model 630G pumps from before October 2019 and all Model 670G pumps from before August 2019 were subject to the recall. Here, there were nearly half a million units worldwide that were subject to the recall. In the U.S., this recall impacted 322,200 pumps. After these dates, Medtronic made changes to the pump design so that the retainer ring can better withstand damage if it is dropped or bumps up against something.
Other Medtronic Pumps Have Also Had Safety Issues
This recall does not affect Medtronic’s Paradigm insulin pump system. This is not the first recall recently relating to a Medtronic insulin pump. Several Medtronic pump models required a recall recently because the remote control system was subject to hacking. These controls had a cybersecurity weakness that left them vulnerable to hackers even though there were no reported injuries from the issue.
Patients who have Medtronic insulin pumps should take this recall seriously given the consequences of a defective pump. They should also speak with their physicians about treatment options. Given that Medtronic is replacing the pump, there should not be too much disruption in patients’ treatment provided that Medtronic can quickly deliver the replacements and patients do not have to stop using their pump without a replacement.
Contact an Attorney to Learn Your Legal Rights
In the event that you were injured by a Medtronic insulin pump, you should immediately consult with a product liability attorney to find out whether you can receive financial compensation for your injuries. The damaged retainer ring could qualify as a design defect that could render the manufacturer legally liable if it was unreasonably dangerous and there was a safer design available. Contact the attorneys at The Law Offices of Sadaka and Associates to discuss your legal options if you have used this series of Medtronic pumps. The consultation is free and without obligation. We provide some of the most aggressive representation when it comes to defective medical devices.