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.
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 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
- Hazard
- burn-injury
- connector-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 (3)
- GTIN: 08714729978725 Lot Numbers: 30521480
- 30521485
- 30521486 Exp. Date: 20-OCT-2024 to 10-Nov-2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03