Agency classClass IIOur severity:High FDA (Devices)·Z-2234-2023·Announced 2023-08-02

Laser fiber medical devices recalled for potential burn injury hazard

Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in 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 potential for burn injury from thermal overheating of the fiber connector. No reported injuries or hospitalizations. Per severity rubric, this meets the threshold for High (3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling Flexiva Pulse ID 242 TracTip laser fibers, single-use devices designed to transmit Ho:YAG laser energy from medical laser consoles to urological anatomy. The recall involves 280 units manufactured with an incorrect component.

The manufacturing defect affects the device's performance and safety. The incorrect component results in lower power output and degradation of the aiming beam, reducing the efficiency of the fiber. Continued use may cause the fiber connector to overheat, which could result in a burn injury if the connector is touched.

The affected devices have been distributed in the United States and Canada. The recall includes 5 specific lot numbers: 30389516, 30389520, 30389525, 30429871, and 30479615, with expiration dates from October 20, 2025 to November 3, 2025. Healthcare facilities and providers using these devices should immediately discontinue use of the affected lots and contact Boston Scientific for a replacement or credit.

The recalled product

Product: Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Surgical / Laser Fiber
Hazard: burn-injury
device-malfunction
Affected units: 280

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: 08714729978763 Lot Numbers: 30389516
30389520
30389525
30429871
30479615 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