Z-2106-2020Class II

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod...

Name: Z-2106-2020 Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod...
Creator: Medtronic Inc.
Published: 2019-05-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-05-20 / Open, Classified / root cause: software

FDA source

Medtronic Inc. began a recall of Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices on 2019-05-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2106-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-20
Posted: 2020-05-22
Recalling firm: Medtronic, Inc.
Product: Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 23,978
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2106-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2106-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)