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
Reported: August 2, 2023 Initiated: May 25, 2023 #Z-2230-2023
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 1245 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boston Scientific Corporation. Units affected: 1245 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2230-2023.
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