Recall Z-0050-2021 ยท PDU Catheter For Crossing Total Occlusions
Ra Medical Systems, Inc.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
| Date | Jul 24, 2020 |
| Status | Terminated |
| Reason | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| Root cause | Device Design |
| Action | On August 10, 2020, the firm sent an "Urgent Medical Correction" letter to customers, informing them of the incorrect laser wheel size, which upon moving or adjusting the laser with the wheels in locked position may fall over. If this were to happen during a medical procedure, user or patient injury may occur. |
| Quantity | 54 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan. |
| 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 |