Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with potential for thermal burn injury if the fiber connector is touched during use. No injuries have been reported. The hazard is potential rather than realized, fitting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Flexiva Pulse 242 Single-Use Laser Fibers are medical devices manufactured by Boston Scientific Corporation designed to transmit Ho:YAG laser energy from cleared laser consoles to urological anatomy. The recall involves 66 units with lot number 30554442 and an expiration date of November 16, 2025.
The recalled devices were manufactured with an incorrect component that may result in lower power output and degradation or dimming of the aiming beam, reducing the efficiency of fiber performance.
Continued use of the affected devices may cause overheating of the fiber connector, which could result in a burn if touched. The devices were distributed worldwide, including throughout the United States and Canada.
Users of these devices should discontinue use immediately and contact Boston Scientific Corporation for replacement units or proper disposal instructions.
The recalled product
- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- thermal-hazard
- burn-injury
- power-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-2025
Distribution
Distributed nationwide across the United States.
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