Recall Z-2228-2023— Boston Scientific Corporation

Name: FDA recall Z-2228-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2023-05-25. It names one FDA 510(k) clearance: K210925. Product: 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. 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.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-05-25
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K210925 — Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberBoston Scientific·cleared 2021-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.