Ra Medical Systems Inc: Medical Device Recall in 2019 - (Recall #: Z-2218-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 15, 2018

Date Posted: August 14, 2019

Recall Number: Z-2218-2019

Event ID: 83348

Reason for Recall:

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

Status: Terminated

Product Quantity: 4

Code Information:

Serial Numbers: 0016, 0039, 0044, 0048

Distribution Pattern:

U.S: CA, PA

Voluntary or Mandated:

Voluntary: Firm initiated