Device recall: Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE…

Class II FDA enforcement event 85344. Recall start date: 19 Sep 2019. Status in the FDA record: Terminated. Termination date: 31 Jul 2023.

Reason for recall, in the words of FDA

The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Ra Medical Systems, Inc. started this device recall on 19 Sep 2019. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class II. FDA event 85344 has 1 product record. The first FDA enforcement report date is 20 May 2020. The record gives the status Terminated, with the termination date 31 Jul 2023.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan,…

Recalling firm

Ra Medical Systems, Inc., Carlsbad, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 85344: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2006-2020	Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY:…	5082 products	Class II	Terminated	20 May 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 7

Other events of the firm

Other FDA enforcement events of Ra Medical Systems, Inc.
Initiated	Product (first record)	Type	Class	Records
16 Oct 2020	DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease.	Device	Class II	1
24 Jul 2020	DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusi	Device	Class II	1
23 Jan 2020	DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and	Device	Class II	1
23 Aug 2019	Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the ski	Device	Class II	1
15 Feb 2018	The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occl	Device	Class II	1
30 Jun 2014	PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and	Device	Class II	1

Ra Medical Systems, Inc.: all 7 events

Official channels

FDA enforcement report Z-2006-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 85344. https://recallregister.com/fda/ii/85344/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan,…
What quantity of product is in FDA event 85344?: The FDA record gives this quantity: 5082 products
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.