Agency classClass IIOur severity:High FDA (Devices)·Z-2228-2023·Announced 2023-08-02

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Surgical / Urological Laser Fiber
Hazard: thermal-hazard
burn-injury
power-degradation
Affected units: 66

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.

Part of a larger recall action

This product is one of 7 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Boston Scientific Corporation

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