Z-2602-2016Class II

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

Name: Z-2602-2016 Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V)
Creator: Medtronic Neuromodulation
Published: 2016-06-10
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-06-10 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V) on 2016-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2602-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-10
Posted: 2016-08-19
Terminated: 2016-10-03
Recalling firm: Medtronic Neuromodulation
Product: Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.
Quantity in commerce: 70
Distribution: US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Product codes and lots: lots: VA15GPJ, VA15K3N, VA15K7K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2602-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2602-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)