Reported Oct 25, 2017 · Terminated
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;…
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
9735559 | VCLAS (Visualase Cooled Laser Ablation System) Visualase Cooled Laser Applicator System 3mm Tip |
9735560 | Visualase Cooled Laser Applicator System 10mm Tip |
9735561 | Visualase Cooled Laser Applicator System 15mm Tip |
- Amount recalled
- 423 devices
Where it was sold
- Nationwide
Why it was recalled
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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