Class 2 Device Recall Guardian Connect App CSS7200

• Date Initiated by Firm: July 04, 2018
• Create Date: May 03, 2019
• Recall Status: Terminated on June 06, 2022
• Recall Number: Z-1282-2019
• Recall Event ID: 81656
• PMA Number: P160007
• Product Classification: Sensor, glucose, invasive - Product Code MDS
• Product: Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
• Code Information: UDI - (01)00643169693142(10)
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Pamela Reese; 818-576-3398
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MDS