Medtronic Neuromodulation: Medical Device Recall in 2016 - (Recall #: Z-2602-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

Product Classification:

Class II

Date Initiated: June 10, 2016

Date Posted: August 31, 2016

Recall Number: Z-2602-2016

Event ID: 74545

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.

Status: Terminated

Product Quantity: 70

Code Information:

lots: VA15GPJ, VA15K3N, VA15K7K

Distribution Pattern:

US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

Voluntary or Mandated:

Voluntary: Firm initiated