Z-0206-2025 Class II Ongoing
FDA device recall Z-0206-2025 was initiated by Medtronic Neuromodulation on Sep 24, 2024 and is designated Class II. Reason for recall: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device"… The recall status is ongoing. Affected quantity: 39 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product description
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Reason for recall
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Distribution pattern
International distribution to the countries of Germany, UK, and Israel.
Code information
GTIN 00763000813468, Serial Numbers: NND504236H, NND504252H; GTIN 00763000813475, Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; GTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H; GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H; GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0206-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026