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U.S. Department of Health and Human Services

Class 2 Device Recall Reveal LINQ insertable Cardiac Monitor

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  Class 2 Device Recall Reveal LINQ insertable Cardiac Monitor see related information
Date Initiated by Firm February 23, 2016
Create Date March 25, 2016
Recall Status1 Terminated 3 on September 25, 2017
Recall Number Z-1249-2016
Recall Event ID 73494
510(K)Number K132649  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product Reveal LINQ insertable Cardiac Monitor, Model LNQ11.
Monitors subcutaneous ECG continuously.
Code Information All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.  
Recalling Firm/
Manufacturer		 Medtronic Inc.
8200 Coral Sea St Ne
Saint Paul MN 55112-4391
For Additional Information Contact Medtronic Technical Services
800-929-4043
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = MEDTRONIC INC.
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