Recall Z-2006-2020 ยท PDU Catheter For Crossing Total Occlusions
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 Steril
| Date | Sep 19, 2019 |
| Status | Terminated |
| Reason | 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 | 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 ca |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems,Inc, May 24, 2017 |