AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

[Recalled] 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

Q: Is 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 contain recalled?

Yes. 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 contain was recalled by FDA_DEVICE on 15 February 2018. Reason: Lasers/Catheters did not calibrate during set-up prior to use.

Published June 20, 2026

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Product	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 contain
Brand / manufacturer	Ra Medical Systems Inc
Category	device
Issuing authority	FDA_DEVICE
Reference	Z-2218-2019
Country of notice	United States
Risk level	Class II
Hazard type	recall
Notice date	15 February 2018

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Lasers/Catheters did not calibrate during set-up prior to use.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

Shop Recalled DABRA Laser model

Search on Amazon ›Find on eBay ›

As an Amazon Associate and eBay Partner, we may earn from qualifying purchases.

Explore by topic

#recall #device #united-states

Looking up a product? Use ProductGuru — free barcode & product database with 35M+ products. Search by EAN / UPC barcode.