Z-0843-2021Class II

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management...

Name: Z-0843-2021 CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management...
Creator: Medtronic Inc.
Published: 2020-11-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-11-12 / Open, Classified / root cause: design

FDA source

Medtronic Inc. began a recall of CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader... on 2020-11-12. FDA classified it as Class II and gives the reason as "Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0843-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-12
Posted: 2021-01-11
Recalling firm: Medtronic, Inc.
Product: CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
Root cause tag: design
FDA root cause: Device Design
Action: On 11/19/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" Letter via email, fax, mail and/or phone to its U.S. Customer, and on 12/07/2020, the firm initiated O.U.S Notification using approved regional methods. The Notification Letter informs customers that after the release of an updated uploader software version the following issues/scenarios may result: 1. Some reports may be missing all programmed basal rates in the device. This may result in a blank value on the Device Settings report of the 24-hour basal total. 2. Some reports may only display certain programmed basal rates and some basal rates in the device may be missing from the reports. This may result in a miscalculation on the Device Settings report of the 24-hour basal total. The following reports may be affected by these issues include: Device Settings, Daily Review/Daily Details, Weekly Review, and Sensor & Meter Overview. These reports have been utilized to adjust therapy settings or to transfer settings from an old pump to a new pump. If all of the following are true, it could lead to either over- or under-delivery of insulin which may result in low blood glucose (hypoglycemia, loss of consciousness), and/or high blood glucose (hyperglycemia): a) adjustments were made to therapy settings or if therapy settings were transferred from one device to another, and b) these actions were taken based on a report generated using CareLink" uploader version 3.1.5.000 that has missing or incomplete basal rates, and c) you are using Manual Mode The Recalling Firm is instructing customers to: 1. Install the new CareLink" uploader version 3.1.6.000 available within the CareLink" software to each computer where you upload devices. To confirm your current uploader version or to learn how to install the latest uploader, see the FAQ section at the end of this letter. 2. If you have had insulin settings adjusted that may have been made based on an impacted CareLink" report, review your settings
Quantity in commerce: 46,461 affected systems
Distribution: U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US
Product codes and lots: CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424121 CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0843-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0843-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-11

Product code MDS

K151236Class IIMiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)Medtronic Minimed, Inc. / cleared 2015-05-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)