Guardian Connect App CSS7200 iOS and Guardian Connect… recallZ-2106-2020 · Medtronic Inc. · initiated May 20, 2019
Class II Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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 version of the Guardian Connect app. Customers receiving emails were requested to submit email acknowledgements indicating they have read and understood the instructions provided in the Urgent Safety Notice Letter clicking on the button as evidence of receipt. Customers receiving paper-copy notifications were instructed to fill out a response card indicating they had read and understood the notice, and mail the card back with a pre-paid envelope. Customers with invalid email and/or physical addresses will be contacted by telephone. Customers with questions were encouraged to contact 24-Hour Technical Support Team at 1-800-646-4633.
Recall details
- Recall number
- Z-2106-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 20, 2019
- Recalling firm
- Medtronic Inc.
- Quantity
- 23,978
- Product code
- MDS
- FDA submissions
- P160007
- Distribution
- US Nationwide distribution.
Product description
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Guardian™ Connect App CSS7200Medtronic Minimed, Inc. · Sensor, glucose, invasive1 recall0 reports
Other devices under the same FDA submission
1 device cleared under P160007 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Guardian™ Sensor (3) MMT-7020AMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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