Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2602-2016 — Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

U.S. FDA — Device Enforcement · United States · 2016-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2602-2016
Date of alert
2016-06-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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