Z-2602-2016 Class II Terminated
FDA device recall Z-2602-2016 was initiated by Medtronic Neuromodulation on Jun 10, 2016 and is designated Class II. Reason for recall: Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic… The recall status is terminated (terminated Oct 3, 2016). Affected quantity: 70.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jun 10, 2016
- Termination Date
- Oct 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70
Product Description
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Reason for Recall
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
Distribution Pattern
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Code Information
lots: VA15GPJ, VA15K3N, VA15K7K
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2602-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026