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

Recall Z-1191-2013 — Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of ch

U.S. FDA — Device Enforcement · United States · 2013-02-08 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1191-2013
Date of alert: 2013-02-08
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices

Reported risk: There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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