Z-0670-2018Class II

Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software...

Name: Z-0670-2018 Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software...
Creator: Medtronic Inc.
Published: 2017-10-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-10-10 / Terminated / root cause: software

FDA source

Medtronic Inc. began a recall of Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a... on 2017-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0670-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2018-02-21
Terminated: 2021-03-26
Recalling firm: Medtronic, Inc.
Product: 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 code: OZO Automated Insulin Dosing , Threshold Suspend
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: A communication is being sent to all healthcare professionals who had uploaded reports using the universal uploader feature between September 23, 2017 to September 27, 2017. The method is by mail and by email, with a response requested from the healthcare professional to confirm they have received and read the notice. For further questions please call (877) 874-7717
Quantity in commerce: 488 uploads
Distribution: Worldwide Distribution - US Distribution
Product codes and lots: Version 1.12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0670-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0670-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code OZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)