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Terminated

VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

FDA Recall Z-0025-2018 · Posted None

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2017-07-27
Date Terminated2019-08-05
Product Quantity423 devices

Reason for Recall

The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.

Firm Action

All US consignees will be a sent a customer letter, dated July 27, 2017, via FedEx or Email. In addition, customers will be asked to return a signed consignee response form.

Root Cause

Process design

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053087VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEMBiotex, Inc. · 2006-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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