SOLTIVE TFL-AFSWLRecalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00821925044272), received between Nov 4, 2022 and Sep 16, 2026 — classified as 1 injury, 82 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (28 reports).

7 other recalls cover devices cleared under the same FDA submission (K242191); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Communication or Transmission Problem

  It was reported that the pedal would not connect wirelessly to the Laser Footswitch. The issue occurred during maintenance. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791083 ↗
• MalfunctionSep 2, 2026Wireless Communication Problem; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567540 ↗
• MalfunctionJun 2, 2026Communication or Transmission Problem; Activation, Positioning or Separation Problem

  THE CUSTOMER RETURNED THE WIRELESS LASER FOOTSWITCH TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE DEVICE EXHIBITED ERROR 139. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363749 ↗
• MalfunctionJan 2, 2026Connection Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942993 ↗
• MalfunctionSep 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092536 ↗
• MalfunctionSep 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092190 ↗
• MalfunctionMay 6, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THE SUBJECT DEVICE HAD PAIRING ISSUE WITH THE LASER SYSTEM AND ERROR 441 OCCURS WHEN FIBER WAS REMOVED OR CONNECTED. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE. THERE WERE NO REPORT OF PATIENT INVOLVEMENT. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970392 ↗
• MalfunctionOct 30, 2024Output Problem; Output Problem

  IT WAS REPORTED, THE POWERED LASER SURGICAL INSTRUMENT FOOTSWITCH IS DEFECTIVE DUE TO AN ERROR MESSAGE E152. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568960 ↗
• MalfunctionOct 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY PAIRING THE TFL LASER FOOTSWITCH TO THE TFL -PLS SOLTIVE LASER SYSTEM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462341 ↗
• MalfunctionOct 8, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE WIRELESS LASER FOOT SWITCH FAILED TO PAIR DURING PREPARATION FOR USE FOR A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403392 ↗
• MalfunctionSep 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED, THE POWERED LASER SURGICAL INSTRUMENT FOOTSWITCH WOULD NOT PAIR WITH THE LASER SYSTEM. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247068 ↗
• MalfunctionSep 11, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE SOLTIVE SUPER PULSED LASER SYSTEM¿S FOOTSWITCH WAS NOT RESPONDING. THE USER WAS UNABLE TO PAIR THE SYSTEM¿EVEN AFTER REPLACING THE BATTERIES. THE ISSUE OCCURRED DURING PREPARATION FOR A THERAPEUTIC PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT WITHOUT ANY DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192739 ↗
• MalfunctionSep 6, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED, THE TFL LASER FOOTSWITCH-WIRELESS WOULD NOT PAIR. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157299 ↗
• MalfunctionAug 27, 2024Blocked Connection; Connection Problem; Blocked Connection; Connection Problem

  IT WAS REPORTED THAT THE POWERED LASER SURGICAL INSTRUMENT'S WIRELESS FOOTSWITCH COULD NOT BE PAIRED TO SOLTIVE UNIT. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077527 ↗
• MalfunctionJul 24, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED, THAT THE WIRELESS LASER FOOTSWITCH HAD A USER CONNECTIVITY ISSUE AND COULD NOT CONNECT TO THE SYSTEM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821660 ↗
• MalfunctionJul 19, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE POWERED LASER SURGICAL INSTRUMENT HAD ISSUES PAIRING WITH THE WIRELESS FOOT PEDAL. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784204 ↗
• MalfunctionJul 9, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE WIRELESS FOOTSWITCH COULD NOT BE PAIRED TO THE GENERATOR. IT WAS NOT SPECIFIED DURING WHAT TYPE OF DEVICE USAGE THE REPORTED EVENT INITIALLY OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707480 ↗
• MalfunctionMay 24, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED THE LASER FOOTSWITCH DID NOT PAIR WITH THE LASER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391330 ↗
• MalfunctionMay 10, 2024Connection Problem; Connection Problem

  IT WAS REPORTED, THAT THE LASER FOOTSWITCH HAD A USER CONNECTIVITY ISSUE AND COULD NOT CONNECT TO THE SYSTEM. IT IS UNKNOWN HOW THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19290795 ↗
• MalfunctionMay 3, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THE POWERED LASER SURGICAL INSTRUMENT FOOT SWITCH WAS NOT PAIRING AND WOULD STOP PAIRING WHEN PAIRED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238736 ↗
• MalfunctionMar 1, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED, THE WIRELESS LASER FOOTSWITCH WAS NOT WORKING, WAS UNABLE TO BE PAIRED AND PRESENTED THE ERROR 152. THE EVENT OCCURRED DURING THE MIDDLE OF A DIAGNOSTIC CYSTO WITH URETERAL STONE REMOVAL, THAT WAS COMPLETED WITH A CORDED FOOT PEDAL AND A DELAY OF 5 MINUTES WITH EXTENDED ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816595 ↗
• MalfunctionFeb 14, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WIRELESS LASER FOOTSWITCH WAS NOT PAIRING TO THE LASER SYSTEM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707883 ↗
• MalfunctionFeb 14, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT A LEFT URETEROSCOPY, BIOPSY AND LASER ABLATION OF URETERIC TUMOR PROCEDURE WAS BEING PERFORMED. THE CUSTOMER WANTED TO USE THE THULIUM LASER TO ABLATE THE TUMOR BUT THE FOOT PEDAL IS WIRELESSLY CONNECTED TO THE THULIUM LASER MACHINE. THE FOOT PEDAL WOULD NOT CONNECT TO THE MACHINE SO THE THULIUM LASER COULD NOT BE USED. THE CUSTOMER TRIED SWITCHING OFF BLUETOOTH FROM PHONES AS THIS HAPPENED PREVIOUSLY, BUT THIS DID NOT WORK. THE CUSTOMER HAD TO USE ANOTHER DEVICE INSTEAD TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707778 ↗
• MalfunctionFeb 14, 2024Connection Problem; Connection Problem

  IT WAS REPORTED, THAT THE FOOT PEDAL ON THE POWERED LASER SURGICAL INSTRUMENT WAS NOT CONNECTING PROPERLY DURING PREPARATION FOR USE CAUSING THE PROCEDURE TO BE DELAYED BY 45 MINUTES. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707445 ↗
• MalfunctionFeb 14, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED, THE CUSTOMER CANNOT CONFIGURE THE LASER WIRELESS FOOTSWITCH TO THE CONSOLE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER. THE DEVICE WILL NOT BE RETURNED BECAUSE THEY HAVE RESOLVED THE ISSUE. DESPITE, 3+ ATTEMPTS TO OBTAIN FURTHER DETAILS FROM THE CUSTOMER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704523 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242191. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2026 · Feb 27, 2026 · Open, Classified
  Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Descriptio
• Z-1695-2026 · Feb 27, 2026 · Open, Classified
  Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An el
• Z-1922-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200
• Z-1920-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIV
• Z-1923-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL
• Z-1921-2025 · May 6, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A P
• Z-1715-2025 · Apr 4, 2025 · Open, Classified
  Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems