Z-0569-2021Class II

DABRA Laser (RA-308 Excimer Laser)

Name: Z-0569-2021 DABRA Laser (RA-308 Excimer Laser)
Creator: Ra Medical Systems, Inc.
Published: 2020-10-16
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2020-10-16 / Terminated / root cause: design

FDA source

Ra Medical Systems, Inc. began a recall of DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic... on 2020-10-16. FDA classified it as Class II and gives the reason as "Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue...". 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-0569-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Posted: 2020-12-14
Terminated: 2023-01-11
Recalling firm: Ra Medical Systems,Inc
Product: DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Product code: PDU Catheter For Crossing Total Occlusions
Reason for recall: Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/29/2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via certified mail informing them of the potential for the footswitch to fail to operate properly if liquid is spilled near or on the footswitch. On 11/16/2020, the firm sent out an updated customer notification. The firm is instructing customers to discontinue using the footswitch if liquids have been spilled on or splashed on the floor near or on the footswitch. The Recalling Firm will ship a replacement footswitch and will provide shipping materials for users to return the old footswitch. Instructions will be provided on how to install the new footswitch and return the old footswitch. Customers are asked to fill out and return the Acknowledgement and Receipt Form via FAX to 760-867-2706 or email at [email protected]. For any questions, contact the Recalling Firm at: 1-877-635-1800 Monday thru Friday 8:00 a.m. to 5:00 p.m. PST
Quantity in commerce: 36 devices
Distribution: US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.
Product codes and lots: Model Number RA-308 Product/Catalog Number: 1200-0001-01 Serial Numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, 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-0569-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0569-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-14

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)