Medtronic Quick-Set® Insulin Infusion Recall

Three Million Medtronic Quick-Set Infusion Sets for MiniMed® Insulin Pumps Recalled

Medtronic, Inc., has recalled three million Paradigm® Quick-Set® infusion sets used with MiniMed Paradigm insulin pumps. The Paradigm Quick-Sets were recalled because of a defect that may prevent the insulin pump from venting air pressure properly, which could cause the device to deliver too much or too little insulin, resulting in serious injury or death (1).

An infusion set includes thin, plastic tubing that is inserted into the skin to deliver insulin from a pump into the abdomen, thigh, or buttocks. The tubing is usually replaced by the user every three days.

Recall Affects All Lot 8 Sets

According to the manufacturer, approximately 60,000 infusion sets may not work properly (1). This poses a significant risk to patient health. All lot numbers beginning with 8 (for example 8XXXXXX) are subject to the recall. The lot number is marked on both the product box label and on each individual package label.

Blood Sugar Problems and Death

Hyperglycemia (high blood sugar) happens when the body has too little insulin. Symptoms include:

  • frequent urination
  • increased thirst
  • shortness of breath
  • nausea and vomiting
  • diabetic coma

Hypoglycemia (low blood sugar), also referred to as “insulin reaction” in diabetics, results from the body having too much insulin. Symptoms include:

  • shaking
  • dizziness
  • clumsy or jerky movements
  • difficulty paying attention or confusion
  • seizure

Both hyperglycemia and hypoglycemia can be extremely dangerous and require immediate medical attention if left untreated.

We Want to Help

If you or someone you care about used a recalled Medtronic Quick-Set infusion set and was hospitalized with hyperglycemia or hypoglycemia, or if someone you care about used these products and died of an insulin-related problem, we want to do everything in our power to help you.

Sources:

  1. Medtronic Voluntarily Recalls Specific Lots of Paradigm® Quick-Set® Infusion Sets in the United States,” from the Food and Drug Administration. Accessed 2/1/10 via the FDA website at www.fda.gov.
  2. Living with Diabetes,” from the American Diabetes Association. Accessed 2/2/10 via the American Diabetes Association website at www.diabetes.org.

MiniMed®, Paradigm®, and Quick-Set® are all registered trademarks of Medtronic, Inc., and are used here only to identify the products in question.

This law firm is not associated with, sponsored by, or affiliated with the American Diabetes Association, the Food and Drug Administration, Medtronic, Inc., or any of its subsidiaries.

Cases may be referred to another attorney or law firm.