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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Connect Mobile App (CSS7200)

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  Class 2 Device Recall Guardian Connect Mobile App (CSS7200) see related information
Date Initiated by Firm May 20, 2019
Create Date May 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-2106-2020
Recall Event ID 85091
PMA Number P160007 
Product Classification Sensor, glucose, invasive - Product Code MDS
Product Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Code Information Model Number CSS7200 (Guardian Connect App: iOS); Catalog Numbers: MMT-7821 (Guardian Connect Transmitter - GST4C); UPN - 00763000186333.  There are no assigned lot or serial numbers. 
Recalling Firm/
Manufacturer		 Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reeses
818-576-3398
Manufacturer Reason
for Recall		 Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.
FDA Determined
Cause 2		 Software design
Action Urgent Medical Device Safety Notification Letters were sent to patients, health care providers (HCPs), distributors and clinical via email beginning on May 20, 2019 and via USPS certified mail beginning on May 22, 2019 notifying them of a potential issue with the transmitter battery life of the Connect Continuous Glucose Monitoring System. Customers using an Apple device with iOS version 12 or higher were advised to update to the latest version (3.2.4) of the Guardian Connect app on their iPhone as soon as possible. Customers not using iOS 12 or higher were encouraged to update to the latest version of the Guardian Connect app. Customers receiving emails were requested to submit email acknowledgements indicating they have read and understood the instructions provided in the Urgent Safety Notice Letter clicking on the button as evidence of receipt. Customers receiving paper-copy notifications were instructed to fill out a response card indicating they had read and understood the notice, and mail the card back with a pre-paid envelope. Customers with invalid email and/or physical addresses will be contacted by telephone. Customers with questions were encouraged to contact 24-Hour Technical Support Team at 1-800-646-4633.
Quantity in Commerce 23,978
Distribution US Nationwide distribution.
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.
PMA Database PMAs with Product Code = MDS and Original Applicant = MEDTRONIC MINIMED
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