Reveal LINQ insertable Cardiac Monitor recall
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Why was Reveal LINQ insertable Cardiac Monitor 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
- Product
- Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
- Recalling firm
- Medtronic Inc.
- 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.
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)