Medtronic recalls select MiniMed pumps in Europe

Medtronic (NYSE:MDT) is recalling a select number of its MiniMed 620G and 640G insulin pumps due to an issue with the Bolus screen displaying a bolus amount that is not up to date, according to an FDA report filed last week.

Medtronic began notifying customers with the devices on June 19, informing them of an error with the Bolus wizard in which the screen will not time out and end up displaying the wrong bolus amount, according to the FDA filing.

The letter advised patients to not activate insulin delivery on any bolus based on a blood glucose value that is more than 12 minutes old.

1936 units are affected by the recall, distributed to Australia, the Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden and the United Kingdom.

The FDA has classified the recall as a Class II, and no cause for the error has been determined, but Medtronic is investigating the issue, according to the FDA filing.

Medtronic launched the MiniMed 640G globally in January. The pump uses Medtronic’s “SmartGuard” technology, designed to suspend insulin delivery when it senses that the patient’s glucose levels are headed toward a low limit, then resume delivery once glucose levels recover, according to a press release.

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