Z-1408-2023 Class II Ongoing
FDA device recall Z-1408-2023 was initiated by Medtronic Neuromodulation on Mar 17, 2023 and is designated Class II. Reason for recall: Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two… The recall status is ongoing. Affected quantity: 1414 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 26, 2023
- Initiation Date
- Mar 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1414 units
Product description
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Reason for recall
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.
Code information
UDI/DI00763000426361, Serial Numbers: HG56BR6, HG56C4R, HG56CJAH01, HG56CLE, HG586N7, HG586UM, HG58704, HG58VM0, HG58VQH, HG58VQHH01, HG58VY5, HG58W7H, HG58WWC, HG58WYB, HG58WYBH01, HG58X0E, HG597BH, HG597DH, HG597M8, HG59ABH, HG59AFC, HG59AV6, HG59RY0, HG5A9GT, HG5A9VY, HG5A9VZ, HG5AQH0, HG5AQQE, HG5BQ5Y, HG5BQLR, HG5BQPJ, HG5BTW7, HG5BTZX, HG5BU5W, HG5BU77, HG5EPSB, HG5EQ0C, HG5EQ2A, HG5EQ69, HG5F31N, HG5F338, HG5F3AZ, HG5F3EH, HG5F3G6, HG5F3K5, HG5F3NF, HG5FP0Y, HG5FP3B, HG5FP70, HG5FP70H01, HG5FPBE, HG5HQBM, HG5HQF8, HG5LJTL, HG5LJZQ, HG5LK2J, HG5LK4H, HG5LK5Y, HG5LK7C, HG5LK8P, HG5LK92, HG5LKAL, HG5LKC9, HG5LKEL, HG5LKGT, HG5LR02, HG5LR33, HG5LTWA, HG5LTWP, HG5LTXU, HG5LTYY, HG5LU12; UDI/DI 00763000486518, Serial Numbers: HG59ABH, HG59RY0, HG59SJ4, HG59SNC, HG5A9H3, HG5A9NB, HG5A9VY, HG5BQ5Y, HG5BQAW, HG5BQLR.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1408-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026