Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure
Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.
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 source text describes a software functionality failure (data upload) without reporting any injuries, illnesses, or direct physical hazards, fitting the criteria for a moderate severity issue.
Plain-English summary
Medtronic Inc. is recalling the Guardian Connect App CSS7200 iOS. This software is intended for use by patients with a compatible consumer mobile device to monitor their health data.
The recall was initiated because the release of a new software version to the CareLink Personal website caused the iOS app to stop automatically uploading data to the website. This issue affects 3,588 users who have the affected app installed on their devices.
The product was distributed internationally, including in North America (Canada), Latin America (Chile, Colombia, Mexico), Asia Pacific (Australia, India, Japan, Korea, Malaysia, New Zealand, Russia, Singapore, Thailand, Vietnam), Asia (Hong Kong), and various countries in EMEA. Consumers should be aware that their data may not be uploading automatically to the CareLink Personal website.
The recalled product
- Product
- The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Software
- Affected units
- 3,588
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)
- Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404
Distribution
Distribution scope not specified by the agency.
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