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Medtronic continues to have problems with its MiniMed insulin pumps. The U.S. Food and Drug Administration (FDA) recently announced another Class 1 recall for the devices, the most serious type of recall. This is an update on a previous recall for the same devices, implemented because they may give the wrong insulin dosage, potentially causing hyperglycemia or hypoglycemia in patients.

Medtronic First Recalled MiniMed Insulin Pumps in November 2019

Back in November 2019, Medtronic issued a warning letter to healthcare providers alerting them to a dosing issue with the MiniMed 600 series insulin pumps. The company told consumers to examine their pumps for potential damage to the retainer ring, which helps to lock the insulin cartridge into the pump’s reservoir compartment.

If the cartridge isn’t locked in properly, the pump may over-or under-deliver the insulin to the patient. This could cause low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Severe forms of both conditions could be life-threatening.

Here are a couple of examples as to how a defective retainer ring could result in the wrong dose of insulin:

  • The retainer ring is broken or becomes detached. The user inserts the reservoir back into the pump while the infusion set is still connected to the body. The pump could then deliver a rapid and large infusion of insulin.
  • The reservoir is not properly locked into place by the retainer ring. It creates a space between the pump and the reservoir, preventing the pump from pushing the expected insulin into the body. Or the pump may stop working due to water entering it. This could then result in low insulin delivery, which could lead to diabetic ketoacidosis.

Medtronic issued the initial recall in November 2019 after receiving reports of loose reservoirs that could no longer be locked into the pump.

Medtronic Expands Recall to Include Over 460,000 Insulin Pumps

On February 12, 2020, the FDA announced the Medtronic MiniMed 600 series insulin pump recall to the public, noting that the devices could cause serious injury and death. At that point, there were over 26,000 complaints about the pumps not delivering the correct dose of insulin. The recall affected over 320,000 pumps distributed from September 2016 through October 2019.

Now, Medtronic has expanded that recall to include over 463,000 pumps including:

  • Model 630G: distributed between September 2016 and February 2020.
  • Model 670G: distributed between May 2015 and December 2020.

Medtronic will replace any pump that has a clear retainer ring with one that has an updated black retainer ring at no charge. It will also now replace the pump even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.

If you have one of these pumps, visit Medtronic’s recall website and enter the pump serial number to confirm that the pump is affected by this recall. If so, Medtronic advises suggests you stop using the pump and contact the company for a replacement. Do not insert the reservoir back into the pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin dose.

If the reservoir locks in place as it should and the retainer ring is not loose, damaged, or broken, you can keep using the old pump until you get the replacement one.

For questions, call Medtronic’s technical support line at 877-585-0166.

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