—#180672

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K071328
Affected lot / code info: All kits with lot numbers from 0211041602 through 0217695790

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-07-08
Terminated: 2024-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.