—#201729

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K210925
Affected lot / code info: GTIN: 08714729978718 Lot Numbers: 30261914, 30389513, 30429863, 30429864, 30479612 Exp. Date: 02-Oct-2025 to 3-Nov-2025

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Boston Scientific issued Urgent Medical Device Product Removal letter dated May 25, 2023. via Fed'X. Letter states reason for recall, health risk and action to take: Further distribution or use of any remaining product affected by this removal should cease immediately. Please read the rest of this letter carefully and immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Please read carefully through the Removal Instructions included with this notification. Your local sales representative can answer any questions you may have regarding this notification. The Reply Verification Tracking Form (RVTF) enclosed with this Removal Notice must be completed and returned even if you do not have any units from affected lots. 1. Immediately discontinue use and segregate affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. Indicate the quantity of SINGLE units you will be returning for credit If you have product that is listed in Table 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF Return the RVTF via: Email: BSCFieldActionCenter@bsci.com or Fax: BSC Field Action Center 1-763-415-7708 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. and ship affected p

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2023-05-25
Posted by FDA: 2023-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.