FDA Medical Device Recalls (openFDA)
Medtronic MiniMed Inc.: CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
- Recall number
- Z-1501-2016
- Recalling firm
- Medtronic MiniMed Inc.
- Product
- CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
- Status
- Terminated
- Initiated
- 2016-02-19
- Posted
- not on file
- Terminated
- 2016-05-16
- Reason
- Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
- Root cause
- Employee error
- Action
- An Urgent Field Safety Notice was sent to customers on 2/19/16 to make customers aware of an iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 21 CareLink iPro reports. The letter informs customers that the affected CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The letter informs the customers of the requested next steps and to contact Maneesh Shrivastav, Director of Strategy at Medtronics Diabetes by email at maneesh.shrivastav@medtronic.com or call (763) 526-3509 if they have any questions.
- Quantity
- 20
- Distribution
- US: MN
- Lot, serial or model codes
- n/a
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- 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