Medtronic Inc. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of the pumps could deliver incorrect doses of insulin, potentially leading to death or injury. Prior to the recall, the defective pumps caused two hundred diabetics to be hospitalized for elevated blood-sugar levels.
The Medtronic recall involves one lot of Quick-set infusion sets, which are disposable plastic tubes used to infuse diabetes patients from the Medtronic insulin pump. The affected infusion sets have a lot number starting with “8” marked on the product label and on each infusion set package, with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399.
In June 2009, the Food and Drug Administration (FDA) issued a warning letter to Medtronic about the MiniMed pump problems. The agency warned the company that it needed to fix the quality control issues in the plant where the pumps are manufactured. According to the FDA, the plant had a wide range of problems that included poor testing procedures, insufficient record keeping, and plant employees without the proper education or training.
If you or a loved on has suffered severe or life threatening elevated blood-sugar after the use of a Medtronic insulin pump, then you may be entitled to monetary compensation for your injuries and damages.
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