VCLAS — Class II medical device recall Z-0025-2018
Terminated recall by Medtronic Navigation, Inc., reported 2017-10-25, distributed nationwide. The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufact
| Recall number | Z-0025-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2017-07-27 |
| Classified | 2017-10-18 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2019-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 423 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00000212503634, 00000212632884, 00000212783784, 00000213041517, 00000213056030 |
| Lot numbers | 000212141557, 000212148368, 000212354781, 000212384009, 000212434500, 000212438405, 000212465594, 000212473141, 000212504463, 000212507737, 000212510629, 000212549456, 000212553428, 000212624409, 000212626439, 000212632885, 000212647830, 000212656015, 000212660280, 000212664497, 000212698642, 000212701679, 000212707035, 000212715926, 000212745633, 000212745660, 000212753561, 000212756095, 000212760821, 000212782059, 000212795235, 000212796559, 000212823883, 000212823919, 000212827856, 000212838837, 000212846726, 000212846727, 000212854585, 000212856596 and 19 more |
| Model numbers | 9735559, 9735560, 9735561 |
Product
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
Reason for recall
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
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-0025-2018. 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.