CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care

FDA device recall Z-1228-2015 · posted 2015-03-02 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

Reason for recall

The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.

Action taken

Medtronic MiniMed Inc. sent an Urgent Medical Device Correction letter in December 2014 to all affected customers. The firm states in their letter that patients can continue to use their MiniMed 620G and 640G insulin pump systems, and that there is no risk to patients caused by this issue. The firm instructs that when reviewing the CareLink Pro 4.0 or CareLink Clinicial reports from the MiniMed 620G and 640G insulin pumps not to use the Temp Basal graphic for clinical consideration. For questions regarding this recall call 818-567-4700.

Root cause

Software design

Status

Terminated

Product code

LZG

Quantity affected

5 CareLink Pro 4.0 CD ROMs

Distribution

Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)

Date initiated

2014-11-10

Date posted

2015-03-02

Date terminated

2015-03-10

Location

Northridge, CA