Z-1672-2016Class II

Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing...

Name: Z-1672-2016 Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing...
Creator: Medtronic Navigation, Inc.
Published: 2016-05-09
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-05-09 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc. began a recall of Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter... on 2016-05-09. FDA classified it as Class II and gives the reason as "Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1672-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-05-16
Terminated: 2016-12-19
Recalling firm: Medtronic Navigation, Inc
Product: 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 code: GEX Powered Laser Surgical Instrument
Reason for recall: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Medtronic will be sending a Medical Device Safety Notification letter FedEx on May 18, 2016. Each customer will be asked to complete and return a response form to Medtronic. This is a safety alert notification and does not require return of devices. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this action, please contact Medtronic Technical Services at 1-800-595-9709.
Quantity in commerce: 120
Distribution: Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1672-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16

Product code GEX

K053087Class IIVisualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc. / cleared 2006-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)