Company: Medtronic Inc.
Date of Enforcement Report: 1/20/2021
Class II
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.
Recall Number: Z-0843-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. on 11/12/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
46,461 affected systems
DISTRIBUTION
U.S. Nationwide and International