Recall – TMS software software error may lead to incorrect change in therapy

Company: Medtronic Inc.
Date of Enforcement Report: 1/20/2021
Class II


CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions:

Recall Number: Z-0843-2021


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.


Medtronic Inc. on 11/12/2020. Voluntary:  Firm Initiated recall is ongoing.


46,461 affected systems


U.S. Nationwide and International

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

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Instructors: Dr. Peter Rech, Brian Pate

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