—#158404

Product

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 product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K053087
Affected lot / code info: Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip Lots - 000212782059, 000212823919, 000212894256, 000212978141, 000212783784, 000212854585, 000212926008, 000212996201, 000212823883, 000212882619, 000212956163, 000213145362; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip Lots - 000212354781, 000212656015, 000212760821, 000212913269, 000212384009, 000212660280, 000212827856, 000212922387, 000212465594, 000212664497, 000212838837, 000212935278, 000212507737, 000212698642, 000212846727, 000213000097, 000212510629, 000212715926, 000212856596, 000213001255, 000212624409, 000212745633, 000212873863, 000213009483, 000212626439, 000212753561, 000212873873, 000213041517, 000212632885, 000212756095, 000212879480, 000213056030; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip Lots - 000212141557, 000212503634, 000212647830, 000212796559, 000212148368, 000212504463, 000212701679, 000212846726, 000212434500, 000212549456, 000212707035, 000212901580, 000212438405, 000212553428, 000212745660, 000212912501, 000212473141, 000212632884, 000212795235, 000212963182

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2017-07-27
Terminated: 2019-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158404. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.