MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these

FDA device recall Z-1890-2017 · posted 2017-04-28 · Terminated

Recall details

Recalling firm

Medtronic Inc.

Reason for recall

Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.

Action taken

A urgent medical device recall letter was sent to customers on 1/31/17 to inform them that Medtronic has identified a software issue that could prevent the internal battery of the pump from charging. Customers are informed that should the software issue occur, an alarm is triggered and they will see the following message displayed on the pump screen: "Power error detected 00:00 25 Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See user guide. OK." Customers are informed that If they experience the alarm and see the Power error detected message on their pump accompanied by the number 25, then they are instructed to contact the Medtronic HelpLine team at XXXXX for assistance with troubleshooting the error.

Root cause

Software design

Status

Terminated

Quantity affected

42,215 units

Distribution

Europe, Australia, Japan, Singapore

Date initiated

2017-01-31

Date posted

2017-04-28

Date terminated

2017-05-04

Location

Northridge, CA