FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
- Recall number
- Z-1282-2019
- Recalling firm
- Medtronic Inc.
- Product
- Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
- Status
- Terminated
- Initiated
- 2018-07-04
- Posted
- not on file
- Terminated
- 2022-06-06
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- UDI - (01)00643169693142(10)
- 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