CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report

Guardian Connect App CSS7200 used on the iPhone, iPad recalled

Medtronic is recalling Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. The recall was initiated on 4 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI - (01)00643169693142(10)

Quantity recalledApproximately 9,328 registered users

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1282-2019
FDA event ID: 81656
Recalling firm: Medtronic, Northridge, CA
Classification: Class II
Status: Terminated
Recall initiated: 4 Jul 2018
FDA classified: 3 May 2019
Reported: 15 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Medical Software

Timeline

4 Jul 2018	Recall initiated by company
3 May 2019	Classified by FDA	+303 days
15 May 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Questions about this recall

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

Yes. Medtronic recalled Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices on 4 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-1282-2019.

Why was it recalled?

Which lots are affected?

UDI - (01)00643169693142(10)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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