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

Recall Z-1617-2015 — Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

U.S. FDA — Device Enforcement · United States · 2015-04-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1617-2015
Date of alert
2015-04-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Reported risk: Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
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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