Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Summary
The FDA issued a Class II for Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Gua by Medtronic MiniMed. Reason: 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 a.
Details
Source
Device Recall
External ID
Z-0776-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Lot/Code Info: App Version 1.3.0
Quantity Affected: 3235
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-21
Company
Northridge, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic MiniMed has 16 FDA actions in our database, including 12 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed have FDA actions?
Medtronic MiniMed has 16 FDA actions in our database, including 12 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0776-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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