Medtronic Navigation, Inc. recalls VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; P…
- Recall date
- July 27, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0025-2018
- FDA classification
- Class II
- Brand / firm
- Medtronic Navigation, Inc.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Medtronic Navigation, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Medtronic Navigation, Inc.