FDAClass IIJune 3, 2020

Guardian Connect App CSS7200 iOS and Guardian Connect recall: Software Issue

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

Why was Guardian Connect App CSS7200 iOS and Guardian Connect recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Recalling firm
Medtronic Inc.
Quantity
23,978
Distribution
US Nationwide distribution.
Recall date
June 3, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls