Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The DABRA Laser (model RA-308) is designed to provide ultraviolet Recalled by Ra Medical Systems Inc Due to Lasers/Catheters did not calibrate during set-up prior to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ra Medical Systems Inc directly.
Affected Products
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.
Quantity: 4
Why Was This Recalled?
Lasers/Catheters did not calibrate during set-up prior to use.
Where Was This Sold?
This product was distributed to 2 states: CA, PA
About Ra Medical Systems Inc
Ra Medical Systems Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report