FDA Device recall Z-0244-2023
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product by Medtronic Navigation, citing due to a defect in the outer pouch sterile seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0244-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-14 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
Reason
Due to a defect in the outer pouch sterile seal
Identifiers
| code_info | Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 02…Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0244-2023%22
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