FDA Device recall Z-1905-2020
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.…
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.… by Medtronic Navigation, citing the firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber asse….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1905-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-08 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
Product
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
Reason
The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
Identifiers
| code_info | All kits with lot numbers from 0211041602 through 0217695790 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2024-10-16 · Medtronic Navigation - Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
FDA Device · Class I · 2024-05-15 · Medtronic Navigation - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation
All Medtronic Navigation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1905-2020%22
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