Reported Aug 2, 2023 · Ongoing
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Flexiva Pulse 242 ID Trac Single Use Fiber-intended to
- be used as a device that transmits HoYAG laser energy from cleared laser consoles
- to urological anatomy (Single-pack UPN)M006L8406960
- Lot codes and dates
- GTIN08714729978718
- Lot Numbers
3026191430389513304298633042986430479612 Exp
- Date02-Oct-2025 to 3-Nov-2025
- Amount recalled
- 231 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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