Insulin pump manufacturer Medtronic Inc. has issued a recall of approximately three million Quick-set infusion sets for its MiniMed Paradigm insulin pumps due to a manufacturing defect that could result in the delivery of incorrect doses of insulin. This may cause serious injury or death for diabetics using the Medtronic insulin pumps.
STATUS OF MEDTRONIC RECALL LAWSUITS: Product liability lawyers are currently reviewing potential cases for insulin pump lawsuits for individuals who suffered an injury caused by one of the recalled Quick-set infusion sets.
MANUFACTURER: Medtronic Inc.
OVERVIEW: On July 10, Medtronic Inc. indicated that approximately 2%, or about 60,000, Quick-set infusion sets from the MiniMed Paradigm insulin pump may not vent air pressure properly, resulting in correct doses of insulin.
Infusion sets are disposable plastic tubes that deliver insulin from the pump into the patient. They are generally disposed of after three days.
The Medtronic insulin pump recall affected all infusion sets with a lot number starting with “8” marked on the product box label and on each infusion set package.
The FDA has previously issued a warning to Medtronic Inc. regarding problems with quality control at its manufacturing center in Puerto Rico, where the Synchromed and MiniMed Insulin pumps are manufactured. FDA investigators found a broad range of problems that included the plant’s procedures for inspecting products for defects and determining whether those defects were of significant concern.
INSULIN OVERDOSE: Symptoms of an insulin overdose could include:
- Irregular Heartbeat
- Increased Pulse or Heart rate
- Increased Hunger
Anyone that suspects they are suffering from an insulin overdose or another diabetic injury from insufficient delivery of insulin should seek medical attention immediately.