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SOLTIVE recallZ-1921-2025 · Olympus Corporation of the Americas · initiated May 6, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

FDA root cause category: Under Investigation by firm

What the company is doing

On May 6, 2025 URGENT: MEDICAL DECIVE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this letter, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of this letter with the Instructions for Use. You may continue to use the device as per this letter and the Instructions for Use. 3. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0470 c. Complete the form as instructed. 4. If you have further distributed this product, identify and forward them this letter. Olympus requests you to report any complaints, including fiber damage/breaks, smoke, sparks, flare, burning of a device or equipment, unsteady flames, steady flames and burns to a clinician or supporting staff occurring while using the SOLTIVE Laser Systems and SOLTIVE Laser Fibers. Olympus requests that you send the involved fiber(s) to Olympus for complaint investigation purposes. Please report complaints to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail [email protected].

Recall details

Recall number
Z-1921-2025
Status
Open, Classified
Initiated by the company
May 6, 2025
Posted by the FDA
Jun 6, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
1549 units (1025 US, 524 OUS)
Product code
GEX
FDA submissions
K242191
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

Product description

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 Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

Code information (models, lots, serial numbers)

All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under K242191 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96723).

Sources and updates

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