Medtronic Recall

More than 160,000 insulin infusion sets are being recalled because of problems that have caused 200 diabetics to be hospitalized for elevated blood-sugar levels. Medtronic, Inc. today announced that it is recalling all of its Paradigm Quick-set Plus diabetic insulin infusion sets because of problems that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including the above mentioned hospitalizations. Medtronic’s recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers.

Medtronic first warned there were reports of complications arising from the infusion pumps In March 2004. The Paradigm Quick-set Plus infusion sets deliver insulin from an infusion pump to a patient’s body. The complaints involved problems with bending of the infusion set’s cannula or unintentional disconnection of the set at the insertion site. The interruption of insulin flow in diabetics can cause serious problems, including death.

The U.S. Food and Drug Administration (FDA) has classified this voluntary action as a Class I recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

If you or a loved one has been injured by a Medtronic insulin infusion set you may have valuable legal rights. We will evaluate your case for free.

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