The DABRA Laser — Class II medical device recall Z-2218-2019
Terminated recall by Ra Medical Systems Inc, reported 2019-08-14, distributed in CA, PA. Lasers/Catheters did not calibrate during set-up prior to use.
| Recall number | Z-2218-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ra Medical Systems Inc, Carlsbad, CA, United States |
| Recall initiated | 2018-02-15 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Distributed | CA, PA |
| Quantity | 4 |
| Serial numbers | 0016, 0039, 0044, 0048 |
| Model numbers | RA-308 |
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 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.
Reason for recall
Lasers/Catheters did not calibrate during set-up prior to use.
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-2218-2019. 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.