Reported May 15, 2019 · Terminated

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

Medtronic Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219

Is this the product you have?

  • Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Lot codes and dates
  • UDI - (01)00643169693142(10)
Amount recalled
Approximately 9,328 registered users

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 6, 2022 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.