FDA recall Z-0843-2021

Medtronic Inc. · Class II · device

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

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.

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

Key facts

Status: Ongoing
Initiation date: 2020-11-12
Report date: 2021-01-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0843-2021