FDA recall Z-2232-2023

Boston Scientific Corporation · Class II · device

Product

Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911

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.

Key facts

Status: Ongoing
Initiation date: 2023-05-25
Report date: 2023-08-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2232-2023