Boston Scientific Corporation: Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 339 units Lot/code info: GTIN: 08714729978619 Lot Number: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025

UPC codes

08714729978619

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.