—#180063

Product

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C 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: 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.

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

Urgent Medical Device Safety Notification Letters were sent to patients, health care providers (HCPs), distributors and clinical via email beginning on May 20, 2019 and via USPS certified mail beginning on May 22, 2019 notifying them of a potential issue with the transmitter battery life of the Connect Continuous Glucose Monitoring System. Customers using an Apple device with iOS version 12 or higher were advised to update to the latest version (3.2.4) of the Guardian Connect app on their iPhone as soon as possible. Customers not using iOS 12 or higher were encouraged to update to the latest version of the Guardian Connect app. Customers receiving emails were requested to submit email acknowledgements indicating they have read and understood the instructions provided in the Urgent Safety Notice Letter clicking on the button as evidence of receipt. Customers receiving paper-copy notifications were instructed to fill out a response card indicating they had read and understood the notice, and mail the card back with a pre-paid envelope. Customers with invalid email and/or physical addresses will be contacted by telephone. Customers with questions were encouraged to contact 24-Hour Technical Support Team at 1-800-646-4633.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.