FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
- Recall number
- Z-2106-2020
- Recalling firm
- Medtronic Inc.
- Product
- Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
- Status
- Open, Classified
- Initiated
- 2019-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Software design
- Action
- 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.
- Quantity
- 23,978
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P160007"]
- Product code
- MDS
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28