Z-2006-2020Class II

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

Name: 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...
Creator: Ra Medical Systems, Inc.
Published: 2019-09-19
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2019-09-19 / Terminated / root cause: labeling and UDI

FDA source

Ra Medical Systems, Inc. began a recall of 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... on 2019-09-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2006-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Posted: 2020-05-14
Terminated: 2023-07-31
Recalling firm: Ra Medical Systems,Inc
Product: 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: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041
Product code: PDU Catheter For Crossing Total Occlusions
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 9/27/19, the firm sent a "Medical Device Recall" letter to its customers via first class mail and emailed to inform them they are issuing a voluntary recall of DABRA Catheters manufactured within the time period specified below. Copies of letters were provided to Ra Medical Systems' representatives, who will visit current customers. The reason for the recall is that data collected through customer feedback and field case reporting, corroborated by internal testing, suggest that the product shelf life is currently less than the labeled shelf life, which has resulted in a higher catheter calibration failure rate. The product impacted is the DABRA Catheter manufactured from 9/24/18 - 8/26/19. The firm stated that failure to calibrate does not pose a safety risk to patients or users. Ra Medical is not aware of any reports of injury or harm related to this issue, nor is there any safety concerns for patients that have been successfully treated using products defined within this recall. The firm is instructing customer to complete recall acknowledgement form that indicates the quantity of product they have. When the form is returned to Ra Medical, we will send the customer return packaging and a shipping label for them to return the recalled product to our facility. Ra Medical Systems representatives will continue to contact customers until all products are returned, or verified no longer at the customers' sites. Each returned product will have an RMA number assigned per our procedure. It will be tagged and stored in a quarantined area. The firm will contact the customers by phone, email or mail to ensure receipt and/or compliance. Should you have any questions or need further assistance please feel free to contact Ra Medical at (442) 325-5044
Quantity in commerce: 5082 products
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, United Kingdom, Italy, France
Product codes and lots: DABRA 101 Catheter. Ref: 1222-5000-01 Serial Number(s): Manufacturing dates 2018-09-03 to 2019-08-26. Expiration dates: September 2019 to August 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2006-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2006-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

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)