Agency classClass IIOur severity:High FDA (Devices)·Z-2229-2023·Announced 2023-08-02

Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.

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: This FDA Class II recall involves a potential burn injury from device overheating, with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Boston Scientific Corporation is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers due to a manufacturing defect. Affected units were manufactured with an incorrect component that can cause the fiber connector to overheat and degrade the aiming beam.

The defective component reduces device efficiency and can cause the fiber connector to overheat during use, which could result in a burn if touched. The aiming beam may appear dimmed or degraded, potentially affecting device performance during urological procedures.

The recall affects 339 units distributed worldwide, including the US and Canada. Affected lot numbers are 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, and 30554453, with expiration dates from October 20, 2025 to November 3, 2025.

Users of affected devices should stop use and contact Boston Scientific Corporation. The FDA has classified this as a Class II recall.

The recalled product

Product: Flexiva Pulse 242 TracTip 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 : M006L8405960
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Surgical Laser
Hazard: burn-injury
overheating
beam-degradation
Affected units: 339

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 (8)

GTIN: 08714729978619 Lot Number: 30389365
30389368
30389369
30429826
30479399
30479580
30479582
30554453 Exp. Date: 20-Oct-2025 to 3-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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Same hazard · burn injury