Recall Z-0025-2018 ยท GEX Powered Laser Surgical Instrument
Medtronic Navigation, Inc.
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
| Date | Jul 27, 2017 |
| Status | Terminated |
| Reason | The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 423 devices |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM Biotex, Inc., Mar 1, 2006 |