Medtronic Insulin Pumps Recalled by the FDA
Many Type I diabetics rely on insulin pumps to deliver insulin to their bodies on a continual basis throughout the day without the need for daily injections. These insulin pumps are connected to the user through a plastic tube, known as an infusion set. The proper functioning of both the insulin pump and infusion set is crucial. If not administered properly, the delivery of excess or insufficient insulin is potentially fatal.
One of the largest manufacturers of insulin pumps and infusion sets in the world is Medtronic, Inc. Insulin pump users should know that Medtronic, Inc. has issued several Class 1 and Class 2 recalls for their products. These are the most critical recalls, and they indicate the potential for serious injury to patients.
Medtronic’s history of recalls includes:
- June 2009 – FDA Class 1 Recall on Paradigm Quickset Infusion Set
- March 2013 – FDA Class 2 Recall on Medtronic MiniMed Paradigm Insulin Infusion Pumps
- June 2013 – FDA Class 1 Recall on Medtronic MiniMed Paradigm Insulin Infusion Sets
- July 2013 – FDA Class 1 Recall on Medtronic MiniMed Paradigm Reservoirs
- March 2014 – FDA Class 2 Recall on Medtronic MiniMed Paradigm REAL-Time and Paradigm REAL-Time Revel CGM System and MiniMed 530G System
- September 2015 – FDA Class 2 Recall on MiniMed 620G Insulin Pump
- June 2015 – FDA Class 2 Recall on Medtronic MiniMed
- September 2017 – Voluntary Recall of Diabetes Infusion Sets
- November 2019 – FDA Class 1 Recall on MiniMed Models 630G and 670G
The attorneys at Ashcraft & Gerel represent individuals who suffered harm or the loss of a loved one due to a faulty insulin pump, including the Medtronic insulin pump and infusion set.
Recent Recall: MiniMed™ 508, Paradigm™ Series, and 600 Series Insulin Pumps
The MiniMed is popular among Type diabetes patients and recent recalls of various products have affected hundreds of thousands of Americans. If you are using one of these products, it could have a dangerous flaw. Here’s what you need to know.
MiniMed 508 and MiniMed Paradigm™ Insulin Pump Hacking Risk
On June 27, 2019, the FDA issued a recall for all Medtronic MiniMed™ 508 Insulin Pump and MiniMed™ Paradigm™ Series Insulin Pumps. These specific product models were found to be vulnerable to cybersecurity risks.
The MiniMed™ 508 and MiniMed™ Paradigm™ were designed to communicate over a wireless radio frequency to other devices like glucose sensor transmitters and blood glucose meters. A person with the right technical skills could potentially hack a nearby insulin device and change the settings that control insulin delivery, resulting in hypoglycemia, hyperglycemia, and diabetic ketoacidosis.
Medtronic is currently issuing a recall of the following device models & software versions:
- MiniMed™ 508 –All versions
- MiniMed™ Paradigm™ 511 –All versions
- MiniMed™ Paradigm™ 512/712 –All versions
- MiniMed™ Paradigm™ 515/715 –All versions
- MiniMed™ Paradigm™ 522/722 –All versions
- MiniMed™ Paradigm™ 522K/722K –All versions
- MiniMed™ Paradigm™ 523/723 –Version 2.4A or lower
- MiniMed™ Paradigm™ 523K/723K –Version 2.4A or lower
- MiniMed™ Paradigm™ 712E –All versions
- MiniMed™ Paradigm™ Veo 554CM/754CM –Version 2.7A or lower
- MiniMed™ Paradigm™ Veo 554/754 –Version 2.6A or lower
You can read Medtronic’s full recall notice here.
MiniMed 600 Series Insulin Pump Inaccurate Dosage Risk
In November 2019, Medtronic initiated a recall for two of their 600-series Insulin Pump models:
- Model 630G (MMT-1715), which was distributed between Sept. 2016 and Oct. 2019
- Model 670G (MMT-1780), which was distributed between June 2017 and Aug. 2019
The malfunctioning models mentioned above may fail to hold the insulin cartridge in place, resulting in under- or over-delivery of insulin. So far, Medtronic has received over 26,000 reports of defective products; at least 2,175 of affected patients have been seriously injured and 1 passed away.
If you have one of these insulin pumps, read Medtronic’s full safety notification for instructions on how to inspect the product.
Medtronic’s Recalled Insulin Pumps Endanger Diabetes Patients
If you own a Medtronic insulin device, we recommend checking your model number immediately to see if it has been recalled. You can speak to your medical provider about switching to a safer model or call Medtronic at 1-866-222-2584 if you have questions about replacing your recalled device. You can also reach out to our offices to discuss your recall case with our experienced team.
Risks Associated with Defective Medtronic Insulin Pump & Infusion Sets
Class I recalls are the most serious category of recalls issued by the FDA. This type of recall indicates that the product defect could potentially cause serious injury. According to the official FDA website, a Class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or even death.”
Medtronic’s defective insulin pumps put diabetic patients at risk of receiving too much or too little insulin, which can have potentially fatal results for thousands of people. One of the most dangerous risks associated with insulin overdose is hypoglycemia, a condition in which a person’s blood sugar (glucose) is too low. Hypoglycemia can result in seizures, coma, brain injury, or even death.
Diabetes patients who begin to develop any of the following signs or symptoms should seek medical attention immediately as they may be experiencing an insulin overdose:
- Severe headache
- Increased/rapid heartbeat
- Tremors, anxiety
- Uncontrolled sweating
If you or a loved one has suffered complications from using a Medtronic insulin pump or infusion set, please contact us. You may be entitled to compensation. All consultations are completely free and are confidential.
To speak with an attorney, call today at (866) 709-0505.