FDAnews Device Daily Bulletin

Medtronic Recalls MiniMed Pumps

July 30, 2015

Medtronic is recalling its Minimed 620g and 640g insulin pumps because its set bolus screen will not always timeout, which can create confusion by showing a bolus amount that is not accurate, according to an FDA posting last week labeling the recall a Class II.

The Irish devicemaker began alerting customers to the problem June 19, warning them against activating insulin delivery on any bolus based on a blood glucose value older than 12 minutes.

No cause for the problem has been determined, but Medtronic says it is investigating the defective products.

A total of 1,936 units are affected, spanning Australia, the Czech Republic, Denmark, Finland, France, Ireland, the Netherlands, Norway, Sweden and the UK. — Jason Scott