Z-0567-2013 Class II Terminated
FDA device recall Z-0567-2013 was initiated by Medtronic Neuromodulation on Dec 3, 2012 and is designated Class II. Reason for recall: Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly… The recall status is terminated (terminated Nov 14, 2013). Affected quantity: 140 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Dec 3, 2012
- Termination Date
- Nov 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140 units
Product Description
Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.
Reason for Recall
Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.
Distribution Pattern
Worldwide Distribution -- USA (nationwide) including the states of CT, MI, NH, NY, OH, PA and VT., and the countries of AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
Code Information
NHU236350V to NHU236373V; NKN037257V to NKN037259V; NKN037372V to NKN037387V; NKN037476V to NKN037507V; NKN037692V to NKN037698V; NKN037772V to NKN037779V; NKN037790V to NKN037810V; NKN037812V to NKN037840V.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0567-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026