—#169303

Product

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

FDA product code: MDS — Sensor, Glucose, Invasive
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P160007
Affected lot / code info: UDI - (01)00643169693142(10)

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.

Root cause (FDA determination)

Software design

Action the firm took

A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018.

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-07-04
Terminated: 2022-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.