Agency classClass IIOur severity:High FDA (Devices)·Z-2231-2023·Announced 2023-08-02

Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component

Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.

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 recall involves a defective medical device creating a credible risk of burn injury from fiber connector overheating, with no injuries yet reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Boston Scientific Corporation is recalling Flexiva Pulse ID laser fibers intended to transmit Ho:YAG laser energy from cleared laser consoles to urological anatomy. Approximately 112 units were manufactured with an incorrect component.

The incorrect component may result in lower power output and dimming of the aiming beam, reducing the efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn if touched.

The affected fibers have been distributed nationwide in the United States and in Canada. Affected lot numbers include 30389427, 30389429, 30389431, 30521475, 30521476, and 30521477, with expiration dates between October 20, 2025 and November 10, 2025. Users who have these devices should discontinue use and contact Boston Scientific for replacement or return instructions.

The recalled product

Product: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Surgical Laser
Hazard: burn-injury
overheating
component-defect
Affected units: 112

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 (6)

GTIN: 08714729978671 Lot Numbers: 30389427
30389429
30389431
30521475
30521476
30521477 Exp. Date: 20-Oct-2025 to 10-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