Z-1368-2021 Class II Ongoing
FDA device recall Z-1368-2021 was initiated by Medtronic Neuromodulation on Mar 9, 2021 and is designated Class II. Reason for recall: There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the… The recall status is ongoing. Affected quantity: 5332 downloads.
Recall details
- Product Type
- Devices
- Report Date
- Apr 14, 2021
- Initiation Date
- Mar 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5332 downloads
Product description
Reason for recall
Distribution pattern
Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, 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-1368-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026