Z-1282-2019Class II

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices

Name: Z-1282-2019 Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices
Creator: Medtronic Inc.
Published: 2018-07-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-07-04 / Terminated / root cause: software

FDA source

Medtronic Inc. began a recall of Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices on 2018-07-04. FDA classified it as Class II and gives the reason as "The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1282-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-04
Posted: 2019-05-03
Terminated: 2022-06-06
Recalling firm: Medtronic, Inc.
Product: Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
Root cause tag: software
FDA root cause: Software design
Action: A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018.
Quantity in commerce: Approximately 9,328 registered users
Distribution: Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.
Product codes and lots: UDI - (01)00643169693142(10)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1282-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)