Z-1228-2015Class III

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

Name: Z-1228-2015 CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance...
Creator: Medtronic MiniMed Inc.
Published: 2014-11-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-11-10 / Terminated / root cause: software

FDA source

Medtronic MiniMed Inc. began a recall of CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic... on 2014-11-10. FDA classified it as Class III and gives the reason as "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...". 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-1228-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-03-02
Terminated: 2015-03-10
Recalling firm: Medtronic, Inc.
Product: CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 5 CareLink Pro 4.0 CD ROMs
Distribution: Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)
Product codes and lots: Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1228-2015	Class III	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

Product code LZG

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)