Z-2898-2016Class II

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose...

Name: Z-2898-2016 CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose...
Creator: Medtronic Inc.
Published: 2016-08-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-08-05 / Terminated / root cause: software

FDA source

Medtronic Inc. began a recall of CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively... on 2016-08-05. FDA classified it as Class II and gives the reason as "Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error". 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-2898-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-05
Posted: 2016-09-27
Terminated: 2016-10-20
Recalling firm: Medtronic, Inc.
Product: CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Product code: PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Reason for recall: Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Root cause tag: software
FDA root cause: Software design
Action: Medtronic sent an Urgent Field Corrective Action letter dated August 5, 2016, to affected customers who received the CareLink iPro Therapy Management Software. The letter informed the customers that the recall affects the users of CareLink iPro software who have downloaded reports that include data that was uploaded from certain models of Roche BG meters. Customers were informed that the recall is due to time stamp error and data from certain Roche meters uploaded to CareLink iPro may resulted in incorrect reports. Customers were informed that if they manually enter Logbook data from the Roche ACCU-CHEK meters or upload data from a blood glucose meter other than the Roche meters are not affected by the recall situation. Customers with any questions regarding the recall letter are instructed to contact the Medtronic 24-Hour HelpLine at 1.800.646.4633. For questions regarding this recall call 818-576-4700.
Quantity in commerce: 33 units
Distribution: Nationwide Distribution to TN, MN, and WA
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2898-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2898-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code PHV

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)