Recall Z-2228-2023 ยท GEX Powered Laser Surgical Instrument
Boston Scientific Corporation
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
| Date | Jul 21, 2023 (initiated May 25, 2023) |
| Status | Open, Classified |
| Reason | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched |
| Root cause | Nonconforming Material/Component |
| Action | Boston Scientific issued Urgent Medical Device Product Removal letter dated May 25, 2023. via Fed'X. Letter states reason for recall, health risk and action to take: Further distribution or use of any remaining product affected by this removal should cease immediately. Please read the rest of this letter carefully and immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization w |
| Quantity | 66 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip La Boston Scientific, Apr 28, 2021 |