Medtronic Navigation, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1672-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.

Product Classification:

Class II

Date Initiated: May 9, 2016

Date Posted: May 25, 2016

Recall Number: Z-1672-2016

Event ID: 74096

Reason for Recall:

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

Status: Terminated

Product Quantity: 120

Code Information:

All lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP

Distribution Pattern:

Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.

Voluntary or Mandated:

Voluntary: Firm initiated