—#144301

Product

Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K132649
Affected lot / code info: All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 8200 Coral Sea St Ne, Saint Paul, Minnesota 55112-4391

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-02-23
Terminated: 2017-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144301. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.