Z-0025-2018 Class II Terminated
FDA device recall Z-0025-2018 was initiated by Medtronic Navigation, Inc. on July 27, 2017 and is designated Class II. Reason for recall: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. The recall status is terminated (terminated August 5, 2019). Affected quantity: 423 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- July 27, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 423 devices
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
Reason for Recall
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Distribution Pattern
US nationwide distribution.
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