Z-1249-2016 Class II Terminated
FDA device recall Z-1249-2016 was initiated by Medtronic Inc. on Feb 23, 2016 and is designated Class II. 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… The recall status is terminated (terminated Sep 25, 2017). Affected quantity: 189,009.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2016
- Initiation Date
- Feb 23, 2016
- Termination Date
- Sep 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189,009
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1249-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026