FDA Device recall Z-0025-2018
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip by Medtronic Navigation, citing the VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0025-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-27 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
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
Reason
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Identifiers
| code_info | Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip Lots - 000212782059, 000212823919, 000212894256…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, 0002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2018%22
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