Medtronic Recalls Insulin Infusion Sets

Risk of overdose, hypoglycemia, coma and death

On September 11, 2017, Medtronic announced a “worldwide recall”  of  “specific lots of infusion sets” containing a “certain discontinued component in these sets.”  It noted that “through recent field reports from patients and a root cause analysis” Medtronic determined that “a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing.  This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.  Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change.”

The problem which led to the re-design of the infusion sets was first discovered in 2013 and led to an “Urgent Medical Device Safety Notification” in June 2013 alerting patients and physicians of the risk of over-delivery of insulin “if insulin or other fluids contact the inside of the Medtronic Paradigm Tubing Connectors.”  The notice informed patients and physicians that “[t]he fluids—which include insulin spilled during priming–can temporarily block the vents in the connector that allow the pump to properly prime.  The letter warned that “[i]f these vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia, which, in extreme cases, may cause loss of consciousness or death.

In 2013, however, the company did not, as it is doing now, recall the infusion sets and these sets with the old design remained on the market for nearly 4 years.

If you are or someone you know is a Type I diabetic who suffered an insulin overdose while utilizing a Medtronic MiniMed Paradigm or Revel insulin infusion pump, we may be able to help you.  At Williams Cedar, our lawyers have experience with these claims and with the particular problem relating to the infusion sets.  We have assisted other patients injured by these devices and may be able to help you. Call us today at 215-557-0099 or submit an online inquiry.



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