Z-0050-2021Class II

DABRA RA-308 Excimer Laser, SN: ******* -

Name: Z-0050-2021 DABRA RA-308 Excimer Laser, SN: ******* -
Creator: Ra Medical Systems, Inc.
Published: 2020-07-24
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2020-07-24 / Terminated / root cause: design

FDA source

Ra Medical Systems, Inc. began a recall of DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease on 2020-07-24. FDA classified it as Class II and gives the reason as "Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0050-2021
Classification: Class II
Status: Terminated
Initiated: 2020-07-24
Posted: 2020-10-02
Terminated: 2023-08-09
Recalling firm: Ra Medical Systems,Inc
Product: DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Product code: PDU Catheter For Crossing Total Occlusions
Reason for recall: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Root cause tag: design
FDA root cause: Device Design
Action: On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur.
Quantity in commerce: 54 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.
Product codes and lots: Model Number DABRA Excimer Laser RA-308; Serial Numbers: RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0050-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0050-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-02

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)