The Recall Desk
HighFDA (Devices)·Z-1890-2017·Announced 2017-05-10

Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly

Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a critical medical device (insulin pump) shutting down due to battery depletion, which poses a significant risk of harm to users, but no specific injuries or deaths are reported in the source text.

Plain-English summary

Medtronic Inc. is recalling 42,215 units of MiniMed 620G and MiniMed 640G insulin pumps. The affected devices are those with software version 2.6 and below, identified by catalog numbers MMT-1510, MMT-1710, MMT-1711, and MMT-1712.

The recall is due to a software anomaly that can prevent the internal battery of the pump from charging. When this anomaly occurs, it leads to battery depletion and subsequent pump shutdown. The affected units were distributed in Europe, Australia, Japan, and Singapore.

Consumers should check their pump's software version and serial number against the list of affected units. If the device is affected, users should contact Medtronic for instructions on how to proceed, as the pump may stop functioning due to battery depletion.

The recalled product

Product
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Manufacturer
Medtronic Inc.
Affected units
42,215

Distribution

Distribution scope not specified by the agency.