Z-1905-2020Class II

Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm...

Name: Z-1905-2020 Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm...
Creator: Medtronic Navigation, Inc.
Published: 2019-07-08
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2019-07-08 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS... on 2019-07-08. FDA classified it as Class II and gives the reason as "The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1905-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Posted: 2020-05-06
Terminated: 2024-10-16
Recalling firm: Medtronic Navigation, Inc
Product: Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued its first customer notification and customer response form on 7/8/2019. On 7/16/2019, a second notification was issued to allow customers to identify recalled product by lot number. On 10/3/2019, the firm issued a third customer notification to include three additional affected lots. The firm requested customers examine inventory for affected lot numbers and quarantine for return to the firm and to complete the attached customer response form.
Quantity in commerce: 4654 units
Distribution: US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK
Product codes and lots: All kits with lot numbers from 0211041602 through 0217695790

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1905-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1905-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code GEX

K071328Class IIVisualase Thermal Therapy SystemBiotex, Inc. / cleared 2007-08-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)