Medtronic Guardian Connect App Recalled for Silent Operating System Shutdowns
Medtronic is recalling the Guardian Connect App because the operating system may close it without warning, preventing users from receiving critical blood glucose alerts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the failure to deliver alerts for hypoglycemic or hyperglycemic events, which poses a risk of harm to users, but the source text does not report specific injuries or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling the Guardian Connect App CSS7200, which is used on iPhone, iPad, and iPod Touch devices. The recall involves approximately 9,328 registered users. The product was distributed only outside the United States, with sales in countries including Austria, Australia, Germany, the United Kingdom, and others.
The recall is due to a software issue where the mobile operating system may close the application without alerting the user. When this happens, the app stops communicating with the transmitter, and the user does not receive alerts associated with hypoglycemic or hyperglycemic events. This lack of notification could result in users missing critical health information.
Users of the Guardian Connect App should check for software updates or contact Medtronic for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible health consequences.
The recalled product
- Product
- Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
- Manufacturer
- Medtronic Inc.
- Affected units
- 9,328
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI - (01)00643169693142(10)
Distribution
Distribution scope not specified by the agency.
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