medical Class II Updated 2023-08-02

Boston Scientific Corporation recalls Flexiva Pulse ID-intended to be used as a device that transm

Recalled Product

Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-Nov-2025
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