Agency classClass IIOur severity:High FDA (Devices)·Z-2233-2023·Announced 2023-08-02

Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component

Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.

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 is an FDA Class II medical device with a potential burn injury risk from connector overheating. As no injuries have been reported in the source material, it meets the criteria for a risk-of-harm product without documented injury.

Plain-English summary

Boston Scientific Corporation is recalling the Flexiva Pulse 242 ID Trac Single Use Fiber, a medical device used to transmit Ho:YAG laser energy during urological procedures. The recall affects 231 units manufactured with an incorrect component.

The defective component results in lower power output and degradation of the aiming beam, reducing the fiber's performance efficiency. More significantly, continued use may cause the fiber connector to overheat, creating a burn hazard if touched.

The affected devices were distributed worldwide, including throughout the United States and Canada. Healthcare facilities and practitioners using these devices should discontinue use immediately and contact Boston Scientific for replacement or return instructions.

The recalled product

Product: Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Surgical / Urological Equipment
Hazard: burn-injury
overheating
power-degradation
Affected units: 231

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 (5)

GTIN: 08714729978718 Lot Numbers: 30261914
30389513
30429863
30429864
30479612 Exp. Date: 02-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

See all →

Moderate
Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · burn injury