According to a report by Medpage Today, the Food and Drug Administration (FDA) has issued a Class I recall of Medtronic MiniMed Paradigm Insulin Infusion Sets due to a defect that could potentially cause patients to suffer serious illness or even death.
The portable device was designed to replace injections for diabetic patients in maintaining blood sugar levels. It gradually pumps insulin into the patient through an infusion set that involves a tube being attached beneath the skin.
If insulin or any other fluid comes into contact with the pump’s tubing connectors, its vents may experience temporary blockage. This blockage can lead to improper levels of insulin delivery and consequently harm or even kill a patient.
HNGN states around half a million patients from all over the world were using the device, switching to new replacements every two or three days. Infusion pumps manufactured between October 2001 and June 2013, 37 different models in total, are affected by the recall.
On June 7, Medtronic notified medical professionals of the pump’s safety issues. A few days later, on June 10, customers and distributors received notice of the defect along with mitigation instructions.
You can read more about the defective insulin pumps by visiting the Medtronic website. If you are a patient using a Medtronic insulin pump and have noticed any leakage, you should immediately stop all usage of the product and call the Medtronic hotline at (888) 204-7616.
If you have suffered an illness or experienced the death of a loved one due to this product or any other defective product, you should get in touch with the Atlanta medical product liability lawyers at The Law Offices of Wayne Grant, P.C. We can help you build a strong case for your injury or wrongful death claim and gain you the compensation you need to get back on the road to recovery. Call us today at (866) 249-5513 for no-cost, obligation-free consultation.