Ra Medical Systems, Inc. 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: 19-09 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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: 19-09
Brand
Ra Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Ra Medical Systems, Inc. is recalling Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09 due to The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the produ. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by 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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026