Diabetic patients rely on an insulin pump rely on their device to deliver insulin correctly. When it does not do its job, manufacturers may recall the device but not always before it causes injury.
According to the FDA, there is a database with medical device recalls.
Explanation of insulin pump recalls
An insulin pump recall falls under medical device recalls. Recalls occur when a device needs a correction or removal. Recalled insulin pumps violate FDA law because they are defective and a health risk. Often, an insulin pump recall is a Class I recall.
There are three classes of recalls. Class I occurs when there is a chance that the product can cause serious health consequences and death. Class II occurs if the product causes a temporary or reversible health problem. Class II rarely causes death. Class III, on the other hand, most like will not cause any health problems or injuries.
Example of an insulin pump recall
According to the FDA, in 2019, Medtronic recalled MiniMed insulin pumps. These insulin pumps have a missing or broken retainer ring. Without a functioning ring, you cannot lock the insulin cartridge in place and it can result in over or under-delivery of insulin.
Patients who receive too little or too much insulin could experience hypoglycemia or hyperglycemia. Hyper glycemia can lead to unconsciousness, seizures and death. In this particular case, there were 26,421 complaints, 2,175 injuries and one death.
When an insulin pump malfunctions, it can result in catastrophic consequences. If the pump’s reservoir does not lock or damage the ring, the patient should cease using the device right away.