Medtronic Inc.: Medical Device Recall in 2019 - (Recall #: Z-1282-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 4, 2018

Date Posted: May 15, 2019

Recall Number: Z-1282-2019

Event ID: 81656

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.

Status: Terminated

Product Quantity: Approximately 9,328 registered users

Code Information:

UDI - (01)00643169693142(10)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated