The Recall Desk
ModerateFDA (Devices)·Z-2106-2020·Announced 2020-06-03

Medtronic Guardian Connect App iOS Recall for Battery Life Issues

Medtronic is recalling the Guardian Connect App for iOS due to shortened transmitter battery life on specific iPhone, iPad, and iPod Touch devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional defect (shortened battery life) without reports of injury or serious harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medtronic Inc. is recalling the Guardian Connect App CSS7200 for iOS and the Guardian Connect Transmitter GST4C. The recall involves 23,978 units distributed nationwide in the United States. The products are used on iPhone, iPad, and iPod Touch devices.

The recall is due to a software issue affecting customers using the continuous glucose monitoring system application on devices running iOS software versions 12, 12.1, or 12.2. These users are likely to experience a shortened transmitter battery life, lasting approximately 4-5 days instead of the normal 7 days or more after a full charge.

Customers using the affected software versions should contact Medtronic for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Manufacturer
Medtronic Inc.
Affected units
23,978

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 (3)

  • 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.

Distribution

Distributed nationwide across the United States.

Same hazard · battery life

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