Class 2 Device Recall DABRA Laser System (DABRA Laser Model RA308 and DABRA Catheter Model 101)

• Date Initiated by Firm: September 19, 2019
• Create Date: May 14, 2020
• Recall Status: Terminated on July 31, 2023
• Recall Number: Z-2006-2020
• Recall Event ID: 85344
• 510(K)Number: K170349
• Product Classification: Catheter for crossing total occlusions - Product Code PDU
• 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
• Code Information: 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
• FEI Number: 3004217728
• Recalling Firm/ Manufacturer: Ra Medical Systems, Inc.; 2070 Las Palmas Dr; Carlsbad CA 92011-1518
• For Additional Information Contact: Andrew Jackson; 877-635-1800
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PDU