Medtronic Inc.: Medical Device Recall in 2018 - (Recall #: Z-0670-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.

Product Classification:

Class II

Date Initiated: October 10, 2017

Date Posted: February 28, 2018

Recall Number: Z-0670-2018

Event ID: 78298

Reason for Recall:

Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.

Status: Terminated

Product Quantity: 488 uploads

Code Information:

Version 1.12

Distribution Pattern:

Worldwide Distribution - US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated