Agency classClass IIOur severity:High FDA (Devices)·Z-2232-2023·Announced 2023-08-02

Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard

Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.

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 device with risk-of-harm hazard (potential burn injury from connector overheating). No injuries or hospitalizations reported. Per rubric, risk-of-harm products without reported injury are rated at most High (3).

Plain-English summary

Boston Scientific Corporation is recalling the Flexiva Pulse ID laser delivery fiber, a device used to transmit Ho:YAG laser energy during urological procedures. The recall involves 205 units manufactured with lot numbers 30521480, 30521485, and 30521486, with expiration dates ranging from October 20, 2024, to November 10, 2025.

The affected devices were manufactured with an incorrect component. This defect may result in lower power output and degradation or dimming of the aiming beam, reducing the efficiency of the fiber. More significantly, continued use may cause overheating of the fiber connector, which could result in a burn if touched.

The affected devices have been distributed worldwide, including throughout the United States and Canada.

Healthcare providers and facilities using these devices should discontinue use immediately. Affected users should contact Boston Scientific for instructions regarding replacement or return of the recalled units.

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 (Box of 5)UPN: M006L8406911
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Urological / Ho:YAG Laser Fiber
Hazard: burn-injury
connector-overheating
power-degradation
Affected units: 205

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 (3)

GTIN: 08714729978725 Lot Numbers: 30521480
30521485
30521486 Exp. Date: 20-OCT-2024 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