Medtronic recalls QUICK SET® INFUSION SETS used with MiniMed Paradigm Insulin Pumps!

FOR IMMEDIATE RELEASE - MINNEAPOLIS – July 10, 2009 – Medtronic, Inc. (NYSE:MDT) said today that it has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

Patients should discontinue using "Lot 8" Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package.
Customers are being asked to return any affected infusion sets to the company. 
Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

"Lot 8" Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. No other Medtronic devices or infusion sets are involved in this recall.

According to doctors who treat diabetes, patients' blood glucose levels as a reult of too little insulin can cause frequent urination, muscle stiffness, aching, nausea and dizziness. Blood sugar can rise to a dangerously high (hyperglycemic) level if untrested and result in Ketoacidosis, coma and death.  Too much insulin can cause hypoglycemia (low blood sugar) resulting in dizziness, fainting, confusion, weakness, difficulty speaking, hunger, sweating, seizure, coma and death

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