FDA Recalls Medtronic, Inc. Insulin Pumps Recall Over Insulin Worries

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The U.S Food and Drug Administration announced a recall on Friday of Medtronic’s insulin pump over inconsistent insulin release. The Class I recall involves Medtronic’s MiniMed Paradigm Insulin Infusion Sets. The company sent an urgent safety warning to doctors and other medical professionals last month about a possible temporary block on the vents of the device if the insulin and other fluids come into contact with its tubing connectors. Once the vents are blocked, the patient may receive either too little or too much insulin which could potentially lead to serious illness or death. The FDA issues a Class I recall of a product if there is a reasonable chance that it may cause serious illness or death.

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