The Recall Desk

FDA (Devices) recall action 92570

Boston Scientific Corporation recalled 7 products on 2023-08-02

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2023-08-02
Critical
0
Units
2,478

Why these products were recalled

Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • HighFDA (Devices)··2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.

    Product
    Flexiva Pulse 242 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 : M006L8405910
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-02

    Laser Fiber Devices May Overheat and Cause Burns During Use

    Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

    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. 5-pack UPN: M006L8405961
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component

    Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-02

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-02

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-08-02

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states