On June 10, 2013, Medtronic sent out a letter to patients using its Paradigm Pump, warning of the potential for over- or under- dosing of insulin. In many tragic cases, the warnings arrived too late and were received only by the intended recipients’ grieving families.
The Problems with Medtronic Paradigm Pump:
Diabetics use the Paradigm Pump to control their insulin levels. The pump operates by infusing a programmed amount of insulin into the patient through a flexible tubing system. The safety issue arises when insulin or other fluids come in contact with the inside of the connector on Medtronic Paradigm infusion sets. The inside of the infusion set connector is likely to be exposed to fluid when insulin is spilled on top of the reservoir after filling the vial. This can result in loss of consciousness or death.
The FDA has supplied a list of the models included in the recall.
When were the recalled Medtronic Paradigm Pumps on the market?
The affected products were manufactured from October, 2001 through June, 2013. They were distributed from December, 2001 to June, 2013. This means that for over a decade these defective pumps were distributed to and used by diabetics, putting millions at risk.
Another recall letter went out on July 3, 2013 to patients who had certain lots of MMT-326A and MMT-332A reservoirs used with Paradigm Pumps. The reason for that recall was yet another safety issue, this time involving a leak in the reservoir. According to the notice, a defective manufacturing tool was to blame for the increased potential for leakage. The leakage can cause the patient to receive less insulin than intended. It can also lead to insulin blockage in the infusion set, and a failure of the device to sound an alarm to notify patients.
Do I have a case?
If your loved one passed away and was using an insulin pump manufactured by Medtronic, we can investigate whether the Medtronic Paradigm Pump defects contributed to his or her death. Contact us for a free consultation.
GoldenbergLaw has been representing victims of defective medical devices for over 30 years. We have experience with other cases involving Medtronic devices, and are located close to their headquarters in Minnesota. We have the expertise and experience to hold Medtronic accountable.
If you are unfamiliar with the way medical device lawsuits work, please visit our FAQ page that explains some terms you may hear, such as “mass tort” or “MDL.” For many injured people seeking an attorney, this is their first time having to look for this type of help. Often, their uncertainty or hesitance comes from not knowing which questions to ask.