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.
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: 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
- Hazard
- burn-injury
- overheating
- power-degradation
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.
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