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.
What this means for you
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
- Hazard
- burn-injury
- device-malfunction
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.
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