Visualase Cooled Laser Applicator System — Class II medical device recall Z-1672-2016
Terminated recall by Medtronic Navigation, Inc., reported 2016-05-25. Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
| Recall number | Z-1672-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2016-05-09 |
| Classified | 2016-05-16 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2016-12-19 |
| Countries outside the US | AU, CA, NL |
| Quantity | 120 |
| Model numbers | 001-4003, T03 |
Product
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
Reason for recall
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
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-1672-2016. 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.