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U.S. Department of Health and Human Services

Class 2 Device Recall Guardian Connect App CSS7200

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  Class 2 Device Recall Guardian Connect App CSS7200 see related information
Date Initiated by Firm July 04, 2018
Create Date May 03, 2019
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDTRONIC MINIMED
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