Recall Z-1282-2019— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2018-07-04, terminated 2022-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.. Reason: The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-04
- Terminated
- 2022-06-06
- Firm location
- Northridge, CA, United States
Product description
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Reason for recall
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
Data sourced from openFDA. This site is unofficial and independent of the FDA.