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FDA recalls MiniMed Insulin Pumps for incorrect dosage

The FDA is calling this a 'class 1' recall, the most serious type.
Credit: FDA

GRAND RAPIDS, Mich. — Medtronic is recalling MiniMed insulin pumps for incorrect insulin dosing which according to the FDA, can cause serious injury or death.

The FDA says this is a class 1 recall, the most serious type of recall. 

Medtronic is recalling the insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which can result in hypoglycemia or hyperglycemia, according to the FDA.

The FDA has received over 25,000 complaints of this malfunction, resulting in over 2,000 injuries and 1 death.

What to Do:

On November 21, 2019 Medtronic notified affected customers and advised them to:

  • Examine the retainer ring of their pump.
  • Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections.
  • Continue using the pump if the reservoir locks in place correctly.
  • If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.
  • Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.

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