Recall Z-0569-2021 ยท PDU Catheter For Crossing Total Occlusions
Ra Medical Systems, Inc.
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
| Date | Oct 16, 2020 |
| Status | Terminated |
| Reason | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase. |
| Root cause | Device Design |
| Action | On 10/29/2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via certified mail informing them of the potential for the footswitch to fail to operate properly if liquid is spilled near or on the footswitch. On 11/16/2020, the firm sent out an updated customer notification. The firm is instructing customers to discontinue using the footswitch if liquids have been spilled on or splashed on the floor near or on the footswitch. The Recalling Firm will ship a replacement footswitch and will provide shipping materials for users to return the old footswitch. Instructions will be pr |
| Quantity | 36 devices |
| Distribution | US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: 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 |