medical Class II Updated 2021-01-20

Medtronic Inc. recalls CareLink Personal Software Therapy Management Software Tool

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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