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

Recall Z-1672-2016 — Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial i

U.S. FDA — Device Enforcement · United States · 2016-05-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1672-2016
Date of alert: 2016-05-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation, Inc.
Product category: device
Product type: Devices

Reported risk: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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