Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.
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 FDA Class II recall involves a potential burn injury from device overheating, with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling Flexiva Pulse 242 TracTip Single-Use Laser Fibers due to a manufacturing defect. Affected units were manufactured with an incorrect component that can cause the fiber connector to overheat and degrade the aiming beam.
The defective component reduces device efficiency and can cause the fiber connector to overheat during use, which could result in a burn if touched. The aiming beam may appear dimmed or degraded, potentially affecting device performance during urological procedures.
The recall affects 339 units distributed worldwide, including the US and Canada. Affected lot numbers are 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, and 30554453, with expiration dates from October 20, 2025 to November 3, 2025.
Users of affected devices should stop use and contact Boston Scientific Corporation. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Hazard
- burn-injury
- overheating
- beam-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 (8)
- GTIN: 08714729978619 Lot Number: 30389365
- 30389368
- 30389369
- 30429826
- 30479399
- 30479580
- 30479582
- 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025
Distribution
Distributed nationwide across the United States.
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