FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
- Recall number
- Z-1249-2016
- Recalling firm
- Medtronic Inc.
- Product
- Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
- Status
- Terminated
- Initiated
- 2016-02-23
- Posted
- not on file
- Terminated
- 2017-09-25
- Reason
- Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
- Root cause
- Software design
- Action
- Consignees in US were hand delivered a Medtronic "Medical Device Correction" letter dated February 2016. The letter was addressed to Physician or Healthcare Professional. The letter described the Issue & Patient Management Guidance. For questions contact your local Medtronic Representative or Medtronic Diagnostic Technical Services at 800-929-4043. Outside the U.S., the letter will be mailed or hand delivered to impacted consignees.
- Quantity
- 189,009
- Distribution
- Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.
- Lot, serial or model codes
- All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
- 510(k) numbers
- ["K132649"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 2182208
- Firm city
- Saint Paul
- Firm state
- MN
- 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