Soltive TFL-CPLURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925044586), received between Dec 13, 2022 and Dec 10, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

5 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.

Recalls naming this device

1. Feb 27, 2026Open, Classified

   Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

   Z-1694-2026 · Root cause: Process control · FDA record ↗

2. Apr 4, 2025Open, Classified

   Preset treatment parameters are not consistently being used in accordance with the IFU.

   Z-1715-2025 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Fire; Fire

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774857 ↗
• InjuryDec 13, 2022Output Problem

  PATIENT UNDERWENT SURGICAL LASER TREATMENT OF LEFT URETERAL STONES ON (B)(6) 2022. THE PROVIDER USED THE OLYMPUS SOLTIVE THULIUM LASER WITH 0.4 -1J ENERGY, FREQUENCY OF 16-40JZ, POWER OF 12.8-40W OVER 9MINS 52 SECS FOR TOTAL ENERGY OF 32.57KJ. THE PATIENT UNDERWENT A SECOND LASER LITHOTRIPSY OF LEFT URETERAL STONE ON (B)(6) 2022 WITH THE SAME LASER, 1J ENERGY WITH 20HZ FREQUENCY, 20W POWER OVER 39 MINUTES FOR A TOTAL OF 59.26KJ WAS USED. THE PATIENT RETURNED A THIRD TIME FOR SIMILAR PROBLEM, AND IT WAS DETERMINED THAT HE HAD A SEGMENT OF AVASCULARIZED NONVIABLE URETER THAT REQUIRED CORRECTIVE SURGERY. PATIENT UNDERWENT THE CORRECTIVE SURGERY AND HAS DONE WELL SINCE.

  Patient problems: Laceration(s); Unspecified Kidney or Urinary Problem

  MAUDE report 15977674 ↗

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-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-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-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