Z-2218-2019Class II

The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a...

Name: Z-2218-2019 The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a...
Creator: Ra Medical Systems Inc
Published: 2018-02-15
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2018-02-15 / Terminated / root cause: manufacturing process

FDA source

Ra Medical Systems Inc began a recall of The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries... on 2018-02-15. FDA classified it as Class II and gives the reason as "Lasers/Catheters did not calibrate during set-up prior to use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2218-2019
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Posted: 2019-08-08
Recalling firm: Ra Medical Systems,Inc
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.
Product code: PDU Catheter For Crossing Total Occlusions
Reason for recall: Lasers/Catheters did not calibrate during set-up prior to use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 02/15/18, service technicians started visiting customer facilities to service affected lasers.
Quantity in commerce: 4
Distribution: U.S: CA, PA
Product codes and lots: Serial Numbers: 0016, 0039, 0044, 0048

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2218-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code PDU

K170349Class IIRA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc / cleared 2017-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)