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Guardian™ Connect App

MEDTRONIC MINIMED, INC. · Model CSS7201 · UDI-DI 00763000381097

MDS

510(k) clearances

282,101

Adverse events (321 deaths)

Recalls

Facilities

Description

SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1

Recalls

Date	Firm	Reason
2025-05-07	Medtronic MiniMed, Inc.	The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
2022-11-21	Medtronic MiniMed	An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logge
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
2021-02-26	Medtronic Inc.	Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.