CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

The Dabra Laser recalled by Ra Medical Systems

Ra Medical Systems is recalling The Dabra Laser (, distributed in California, Pennsylvania. The recall was initiated on 15 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 0016, 0039, 0044, 0048

Quantity recalled4

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2218-2019
FDA event ID: 83348
Recalling firm: Ra Medical Systems, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Feb 2018
FDA classified: 8 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

15 Feb 2018	Recall initiated by company
8 Aug 2019	Classified by FDA	+539 days
14 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lasers/Catheters did not calibrate during set-up prior to use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

U.S: CA, PA

California Pennsylvania

Stores named: Target

Questions about this recall

Is The Dabra Laser ( recalled?

Yes. Ra Medical Systems recalled The Dabra Laser ( on 15 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-2218-2019.

Why was it recalled?

Lasers/Catheters did not calibrate during set-up prior to use.

Which lots are affected?

Serial Numbers: 0016, 0039, 0044, 0048

Where was it sold?

U.S: CA, PA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ra Medical Systems

All 7

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	Dabra Laser (RA-308 Excimer Laser) recalled by Ra Medical Systems	Ra Medical Systems	Other	16 states
14 Oct 2020Device	CLASS II	Dabra RA-308 Excimer Laser, SN: ******* recalled by Ra Medical Systems	Ra Medical Systems	Other	Nationwide
15 Jul 2020Device	CLASS II	Dabra Laser (RA-308 Excimer Laser) recalled by Ra Medical Systems	Ra Medical Systems	Device Malfunction	22 states
20 May 2020Device	CLASS II	Dabra Catheter 5F recalled by Ra Medical Systems	Ra Medical Systems	Sterility	Nationwide
8 Apr 2020Device	CLASS II	Pharos Excimer Laser recalled by Ra Medical Systems	Ra Medical Systems	Device Malfunction	Nationwide

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