Defective Medtronic Paradigm Pumps and Infusion Sets

On June 10, 2013, Medtronic sent out a letter to patients using its Paradigm Pump, a device used by diabetics for insulin management, warning of the potential for over or underdelivery of insulin. In many tragic cases, the warnings arrived too late and were received only by the intended recipients’ grieving families.

Case Quick Facts

The Problem

The Medtronic Paradigm Insulin Pumps and associated infusion sets are designed for use by insulin-dependent diabetics. The pump system is designed to operate by delivering specific amounts of insulin to the patient. The insulin delivery occurs when insulin is dispensed from the pump’s reservoir; the insulin then travels through the infusion sets and is delivered to the user via a needle inserted into the patient’s body.

In order to properly function, the pump system is equipped with a piece that connects the pump to the infusion sets. This connector contains vents which allow air to flow through the pump system. However, if this component becomes wet, liquid (including water or insulin) can clog the vents, triggering an over- or under-delivery of insulin to the user. Depending upon a patient’s sensitivity to insulin, even a small difference in the amount being delivered can have a catastrophic impact, including serious injury or death.

The Injuries

An under- or overdelivery of insulin can cause hyper- or hypoglycemia, resulting in loss of consciousness, serious injuries, and death.

The Defendant(s)

The Paradigm insulin pumps are designed and manufactured by Medtronic MiniMed, Inc., a wholly owned subsidiary of Medtronic, Inc. The infusion sets are designed and manufactured by Medtronic MiniMed, Inc. in conjunction with Unomedical S.A. de C.V., Unomedical A/S, and/or Flextronics International USA, Inc.

GoldenbergLaw Can Help

If you or a loved one have experienced an injury due to an over- or underdelivery of insulin from a Paradigm pump, GoldenbergLaw may be able to help. We are actively litigating these cases.

Do I Qualify?

Free Consultations

If you have been negatively affected by a Medtronic insulin pump, you may want to consider an insulin pump malfunction lawsuit. Our team would be happy to hear your case and see what we can do for you. Contact us today for a free consultation.

June 2009 Recall

In late June, 2009, Medtronic issued a recall of Paradigm Quick-Set infusion sets, manufactured over an eighteen-month period between December 1, 2007 and June 18, 2009, due to a defect which might “not allow the insulin pump to vent air pressure properly … [which] could potentially result in the device delivering too much or too little insulin and may cause serious injury or death.” (June 29, 2009 Recall Notice.)

June 2013 Recall

On June 7, 2013, Medtronic initiated a Class I Recall of a variety of Medtronic Minimed Paradigm Insulin Infusion Sets. The recall covered products manufactured from October, 2001 through June,
2013. The recall notice states that the recall was due to “a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the tubing connector. If this occurs it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious illness.”[1] On Sept 11, 2017, Medtronic further recalled many of the Infusion Sets (the plastic tubing) used with its Paradigm Insulin Pumps stating:
The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.

September 2017 Recall

On September 11, 2017, Medtronic announced yet another recall of “specific lots of infusion sets used with all models of Medtronic insulin pumps.”[2] This time, the recall notice specifically identifies the vent in the connector as the source of the problem and indicates that infusion sets sold prior to April 2017 may have contained this component. Patients with recalled infusion sets should immediately discontinue using them, as the blocked vent may result in serious injuries.

Why Choose GoldenbergLaw?

If you are considering filing a Medtronic insulin pump lawsuit, our lawyers should be the first people you contact. Not only do we have experience with Medtronic devices, but we have also spent years working on cases dealing with all sorts of defective medical devices.