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Class 2 Device Recall Guardian App for iOS v. 1.3.0; Guardian App for Android v. 1.3.0 |
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| Date Initiated by Firm |
November 21, 2022 |
| Date Posted |
January 01, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0776-2023 |
| Recall Event ID |
91260 |
| Product Classification |
Sensor, glucose, invasive - Product Code MDS
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| Product |
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system |
| Code Information |
App Version 1.3.0 |
Recalling Firm/
Manufacturer |
Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
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| For Additional Information Contact |
818-576-4700
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Manufacturer 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.
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FDA Determined
Cause 2 |
Software change control |
| Action |
On 11/21/22, correction notices were sent to patients, care partners, and healthcare providers. The following actions were requested of users:
iOS/Android Users:
1) Verify what version of the app you are running by taking the following steps:
a) On the home screen, navigate to the settings menu on the upper left corner
b) Select "Help"
c) Confirm "Version"
2) If you are not running version 1.3.0, no action is necessary
3) If you have version 1.3.0, update to the latest app version currently available in the App Store (1.3.1) by following these steps:
iOS Users:
a) Open the App Store app.
b) Tap your profile icon at the top of the screen.
c) Scroll to see pending updates.
d) Tap update next to the mobile app icon to update the app.
Android Users:
a) Open the Google Play Store app.
b) Tap Menu and then Manage apps & devices.
c) Apps with an update available are labelled "Update available". You can also search for a specific app.
d) Tap Update.
Once you update to version 1.3.1 and log in to the Guardian App all your past data from version 1.3.0 will remain available and visible.
It is not recommended or necessary to uninstall the current version of the app from your phone before installing the new version 1.3.1. If you choose to do so, your local data will not able available in the app and you will be prompted to pair your transmitter.
Complete and return the Customer Confirmation Form. Form can be returned to rs.safetyinformation@medtronic.com
For questions, contact our 24-Hour Technical Support line at 1-800-646-4633, option 1. |
| Quantity in Commerce |
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
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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