Visualase Cooled Laser Applicator System Tubing Set kits Product… — Class II medical device recall Z-1905-2020
Terminated recall by Medtronic Navigation, Inc., reported 2020-05-13, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, inc
| Recall number | Z-1905-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2019-07-08 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2024-10-16 |
| Distributed | 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 |
| Countries outside the US | CH, DE, ES, FR, GB, GR, IL, IS, SE |
| Quantity | 4,654 units |
| Reason classes | device malfunction |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1905-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.