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Medtronic Minimed Recall

Medtronic Minimed Infusion Pump Recall Lawyers

Medtronic issued a Class I recall of their MiniMed Quick-set® Paradigm Infusion Insulin pump on June 29, 2009. Thousands of diabetic patients use this device to monitor their blood glucose levels and assist them in the control of their glucose levels by delivering doses of insulin on a pre-determined schedule.
Medtronic Quick-set® Lot Location

RECALL: “Lot 8” Paradigm Quick-Set MiniMed insulin pumps, Reference # MMT-396, MMT-397, MMT-398 and MMT-399.

The recall of the “Lot 8” Quick-set® Infusion set was due to a problem in the manufacturing of the sets where a lubricant clogged the tubes, which prevented the venting of air from the system. The unequal air pressure in the tubes hinders the proper flow of insulin, causing the user to receive too much or too little insulin.

Complications from Recalled Devices

1. Over delivery of insulin
Due to the loss of ambient air pressure, with improper venting, a large bolus of insulin could be suddenly injected, resulting in a dramatic and potentially fatal drop in blood glucose levels. This can result in the following symptoms:

  • confusion
  • fainting
  • dizziness
  • difficulty speaking
  • sweating
  • weakness
  • hunger
  • Severe hypoglycemia can also lead to seizures, stroke, coma and death

2. Too little insulin is being delivered
When the vent clogs it can prevent equalization of the air pressure at the time of priming of the insulin pump. The patient thinks it is properly primed and assumes the insulin is being delivered as scheduled. A diabetic who may have an elevated blood glucose level does not get the required insulin dose. This causes the glucose level to go up significantly and can result in the patient suffering a hyperglycemic event known as ketoacidosis. This is a very serious complication requiring hospitalization until their blood glucose levels come back to normal. This can result in the following symptoms:

  • frequent urination
  • irregular heart beat
  • shortness of breath
  • muscle stiffness and aching
  • nausea and dizziness
  • If severe, it can lead to arrhythmias, stroke, heart attack, blood clots, decreased consciousness, coma and death.

Medtronic estimated 2% of the 3 million sets did not work properly and approximates this failure adversely affected 60,000 users.

Contact a Medtronic Minimed Infusion Pump Recall Attorney

We are reviewing Minimed Infusion Pump claims and lawsuits. If you or a loved one has suffered complications that might have been caused by a Medtronic Insulin Pump it is important that you contact a New Jersey Medtronic Lawyer today for a free consultation. All lawsuits are being pursued under a contingency fee, which means that there are no fees unless a recovery is obtained.

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