Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Reported: January 11, 2023 Initiated: November 21, 2022 #Z-0776-2023
Product Description
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Reason for Recall
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 logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
Details
- Recalling Firm
- Medtronic MiniMed
- Units Affected
- 3235
- Distribution
- OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom
- Location
- Northridge, CA
Frequently Asked Questions
What product was recalled? ▼
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system. Recalled by Medtronic MiniMed. Units affected: 3235.
Why was this product recalled? ▼
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 logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0776-2023.
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