SOLTIVERecalls & reported problems across all models
Gyrus ACMI, LLC · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
16 open recalls name at least one SOLTIVE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 867
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls
- 17
We found 16 models of SOLTIVE by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 867 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2021 and Sep 30, 2026 — classified as 97 injuries, 770 malfunctions.
The most frequently reported specific device problem is “Break” (201 reports).
17 FDA recall records name at least one of these models by its device identifier, 16 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SOLTIVE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1695-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
- May 6, 2025Open, Classified
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.
Z-1923-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 6, 2025Open, Classified
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.
Z-1922-2025 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- May 6, 2025Open, Classified
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.
Z-1921-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 6, 2025Open, Classified
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.
Z-1920-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 · names 4 of these models · Recall details · FDA record ↗
- Aug 13, 2024Open, Classified
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Z-0135-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 13, 2024Open, Classified
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Z-0134-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 31, 2024Open, Classified
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Z-2506-2024 · Root cause: Device Design · Recall details · FDA record ↗
- May 31, 2024Open, Classified
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Z-2505-2024 · Root cause: Device Design · Recall details · FDA record ↗
- May 31, 2024Open, Classified
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Z-2504-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jan 29, 2024Open, Classified
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Z-1385-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 29, 2024Open, Classified
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Z-1384-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 4, 2023Open, Classified
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Z-0718-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
Z-0748-2024 · Root cause: Labeling Change Control · names 7 of these models · Recall details · FDA record ↗
- May 26, 2022Terminated
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Z-1296-2022 · Root cause: Labeling mix-ups · names 4 of these models · Recall details · FDA record ↗
Most reported SOLTIVE problems
Device problems
- Break201
- Fire122
- Communication or Transmission Problem88
- Smoking67
- Connection Problem57
- Adverse Event Without Identified Device or Use Problem54
- Sparking42
- Wireless Communication Problem38
Patient problems
- No Clinical Signs, Symptoms or Conditions776
- Stenosis19
- Unspecified Kidney or Urinary Problem18
- Urethral Stenosis/Stricture14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Insufficient Information12
- Renal Failure8
- Burn(s)7
SOLTIVE models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOLTIVE TFL-PLSPowered laser surgical instrument6 recalls450 reports
- SOLTIVE TFL-SLSPowered laser surgical instrument6 recalls33 reports
- SOLTIVE TFL-FBX200BSPowered Laser Surgical Instrument4 recalls84 reports
- SOLTIVE TFL-FBX200SPowered Laser Surgical Instrument3 recalls93 reports
- SOLTIVE TFL-FBX550SPowered laser surgical instrument3 recalls63 reports
- SOLTIVE TFL-FBX150BSPowered Laser Surgical Instrument3 recalls18 reports
- SOLTIVE TFL-FBX150SPowered Laser Surgical Instrument2 recalls21 reports
- SOLTIVE TFL-FBX365SPowered Laser Surgical Instrument2 recalls11 reports
- Soltive TFL-CPLUPowered laser surgical instrument2 recalls2 reports
- SOLTIVE TFL-FBX940SPowered Laser Surgical Instrument2 recalls1 report
- SOLTIVE TFL-CSLUPowered laser surgical instrument2 recalls0 reports
- SOLTIVE TFL-AFSWLPowered laser surgical instrument83 reports
- SOLTIVE TFL-AFSWPowered laser surgical instrument1 recall5 reports
- SOLTIVE TFL-FBX940RPowered Laser Surgical Instrument1 recall0 reports
- SOLTIVE TFL-APCUSPowered laser surgical instrument2 reports
- SOLTIVE TFL-AFS 365Powered laser surgical instrument1 report
Recent SOLTIVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Decoupling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946402 ↗MalfunctionSep 29, 2026Power Problem; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935125 ↗MalfunctionSep 25, 2026Break; Fire
The customer reported that a Single Use Fiber broke and generated a small fire upon insertion into the laser port of the Powered Laser Surgical Instrument during a therapeutic ureteroscopy with laser lithotripsy procedure. The event occurred while the patient was sedated, and the device was in use. The fire was extinguished promptly, and no injury or burn to the patient was reported. At the time of the event, no flammable materials, anesthetic agents, or high concentrations of oxygen were being used in the immediate surgical area. The laser equipment was positioned more than five feet away from the patient, and because the patient was intubated, oxygen and anesthetic gases were not present at the surgical site. The procedure was completed using a competitor's laser unit and laser fiber. The patient's outcome was reported as no injuries noted, and no adverse outcome was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898371 ↗MalfunctionSep 24, 2026Sparking; Flare or Flash
It was reported that when the laser of the subject device fired, it sparked and appeared to ignite/burn. There were no reports of patient harm/involvement. During the initial evaluation of the device, the reported event was unable to be confirmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876974 ↗MalfunctionSep 23, 2026Break
The customer returned the Single Use Fiber to the service center for a separate issue. During the device analysis, the investigator indicates that the fiber was broken/damaged, likely due to stress or handling. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871350 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869883 ↗MalfunctionSep 22, 2026Flare or Flash
The customer reported laser fired, sparked, and appeared to ignite/burn during an unspecified procedure involving an Olympus Powered Laser Surgical Instrument. The customer suspected that the cause of the broken fiber tip was due to fluid invasion. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855038 ↗MalfunctionSep 22, 2026Material Fragmentation; Sparking
It was reported that during a therapeutic kidney stone with ureteroscopy and laser lithotripsy, the powered laser surgical instrument sparked at the plug and broke the fiber off of the base while it was inserted inside the laser system. The reported event resulted in a procedural prolongation of less than 30 minutes. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853311 ↗MalfunctionSep 21, 2026Fire
The customer reported laser fiber caught fire during procedure during an unspecified procedure involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50842255 ↗MalfunctionSep 21, 2026Break
The customer reported broken power cord during set up / Inspection for use involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842003 ↗MalfunctionSep 21, 2026Fire
The customer reported Laser fiber was damaged during a therapeutic laser case involving an Olympus Powered Laser Surgical Instrument. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841662 ↗MalfunctionSep 18, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817021 ↗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 16, 2026Damaged Thread
It was reported that the power cord had three exposed wires and without housing on the Olympus SuperPulsed Laser System. The issue occurred during preparation for use. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790939 ↗MalfunctionSep 16, 2026Computer Software Problem
It was reported that the logs for our kilojoules and watts are not matching the treatment log with the Olympus SuperPulsed Laser System. The issue occurred during a therapeutic Laser Lithotripsy procedure. The procedure was completed using a same device. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789882 ↗
Other Gyrus ACMI, LLC products
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
- PK TECHNOLOGY10 models · 24 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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