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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Connect Mobile App

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  Class 2 Device Recall Guardian Connect Mobile App see related information
Date Initiated by Firm July 15, 2020
Create Date September 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-2980-2020
Recall Event ID 86081
Product Classification Sensor, glucose, invasive - Product Code MDS
Product The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Code Information Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404
Recalling Firm/
Manufacturer
Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Kendra Cassillo
818-576-5611
Manufacturer Reason
for Recall
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
FDA Determined
Cause 2
Software design
Action On July 15, 2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" to customers/Care Partners/Healthcare Professionals via email informing them that the Recalling Firm released an update to the CareLink Personal Software. Following the release of the software, several customer using the iOS app experienced data connectivity disruptions and as a result: 1. Care partners may not receive SMS alerts 2. Care partners remote access monitoring in the CareLink Connect web app may show data gaps 3. Customers may see data gaps in their reports. Customer are instructed to: 1. Attempt to manually upload your data to the CareLink" software via the Guardian" Connect app: a. Tap on the top left corner of the Home Screen b. Confirm Sync to CareLink is enabled c. Tap Upload Now d. Wait 10 minutes before moving to step #2. 2. Check your account to see if you are experiencing this issue a. From your mobile device visit https://carelink.minimed.eu and log in to your CareLink" account b. Confirm that your data is visible in the CareLink" Connect web app c. If your data is visible, no further action is needed - you are not experiencing the issue d. If your data is not visible, you may be experiencing the issue and you should complete the steps in the next section to resolve the issue. Instructions for Resolving the Issue (refer to the Frequently Asked Questions included for detailed instructions) 1. If your data was not visible after step #2, uninstall the Guardian" Connect app from your mobile device. For help, please refer to FAQ below #3 2. Unpair your transmitter from your mobile device. For help, please refer to FAQ below #3 3. Re-install the Guardian" Connect app on your mobile device  this will restore the CareLink" connection. For help, please refer to FAQ below #4 *Uninstalling the Guardian" Connect app may delete visible data from the app. All data that has been uploaded to the CareLink" software will continue to be visible in CareLink" report
Quantity in Commerce 3,588 users
Distribution International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada
Total Product Life Cycle TPLC Device Report

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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