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Safety issues are plaguing a popular insulin pump manufactured by Medtronic, which could lead to catastrophic over- or under-delivery of insulin for persons with diabetes, resulting in loss of consciousness or death.

A June 7, 2013  “Dear Healthcare Professional” (DHCP) letter from Medtronic titled “Urgent Medical Device Safety Notification” warns of the “potential for over or under delivery of insulin if insulin or other fluids contact the inside of the Medtronic Paradigm tubing connectors.”

The warnings apply to insulin “Infusion Sets,” which are designed for use with the Medtronic Paradigm family of infusion pumps. The infusion sets are small catheters which deliver insulin from the pump reservoir into the body through a needle.

A manufacturing defect in the “Infusion Sets” may prevent air from being properly vented. Air pressure could potentially result int he device delivering too much or too little insulin, according to the U.S. Food and Drug Administration.

On June 29, 2009 it issued a recall of its Paradigm “Quick Set” infusions sets from “Lot 8” manufactured between December 1, 2007 through June 19, 2009, because of a manufacturing defect. In July, Medtronic sent an urgent recall notice to customers, concerning problems with lots of MMT-326A and MMT-332A.  The July notice was issued because of the risk of reservoir leakage.

If you or someone you know has died or suffered injury related to a Medronic Paradigm pump, call 1-800-883-2299 to discuss your rights.


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