Medtronic Navigation, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0025-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 27, 2017

Date Posted: October 25, 2017

Recall Number: Z-0025-2018

Event ID: 77977

Reason for Recall:

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

Status: Terminated

Product Quantity: 423 devices

Code Information:

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

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated