Recall Z-2106-2020 ยท MDS Sensor, Glucose, Invasive
Medtronic Inc.
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
| Date | May 20, 2019 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 v |
| Quantity | 23,978 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.