ShockPulse SPL-TRecalls & reported problems
Gyrus ACMI, LLC · SHOCKPULSE LITHOTRIPSY TRANSDUCER · Class 2
All models of SHOCKPULSE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Gyrus ACMI ShockPulse lithotripsy transducer uses ultrasonic vibrations to break up stones. The 283 reports often describe the transducer breaking, failing to transmit or produce output, and failing to power up or activate. The reports include no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 279
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 00821925043831), received between Jan 7, 2021 and Sep 28, 2026 — classified as 1 injury, 278 malfunctions.
The most frequently reported specific device problem is “Break” (45 reports).
6 other recalls cover devices cleared under the same FDA submission (K171024); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break45
- Communication or Transmission Problem29
- Output Problem25
- No Device Output19
- Activation Problem18
- Failure to Power Up16
- Activation Failure15
- Connection Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions262
- No Patient Involvement11
- Insufficient Information5
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 279 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Unexpected Shutdown
It was reported that during an unspecified therapeutic procedure, the lithotripsy transducer stopped working during the procedure. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916680 ↗MalfunctionSep 21, 2026Connection Problem
During onsite inspection of the Lithotripsy, it was found Transducer plug is not secured. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847416 ↗MalfunctionSep 16, 2026Failure to Deliver Energy
It was reported that, while using the shockpulse lithotripsy transducer, the shockpulse was not working. Onsite inspection results identified no output from the shockpulse. The issue occurred during set-up/inspection for use. There was no report of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790692 ↗MalfunctionSep 14, 2026Failure to Deliver Energy; Activation Failure
It was reported the Lithotripsy was not producing ultrasonic energy. The issue occurred during Percutaneous nephrolithotomy (PCNL) therapeutic procedure. The procedure was completed using a similar device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752282 ↗MalfunctionSep 10, 2026Failure to Deliver Energy
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721439 ↗MalfunctionSep 9, 2026Break
The customer reported connector broke during set up / Inspection for use involving an Olympus LITHOTRIPSY TRANSDUCER. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693667 ↗MalfunctionSep 9, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693253 ↗MalfunctionSep 9, 2026Energy Output Problem; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692140 ↗MalfunctionMay 20, 2026Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER EXHIBITED NO OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236742 ↗MalfunctionMay 20, 2026Activation Failure
IT WAS REPORTED THAT THE SHOCKPULSE LITHOTRIPSY TRANSDUCER DID NOT WORK WHEN PLUGGED IN. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233318 ↗MalfunctionMay 6, 2026Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER PLUG WAS LOOSENED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095552 ↗MalfunctionApr 30, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY HAD TRANSDUCER PLUG DETERIORATION/DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052997 ↗MalfunctionApr 30, 2026Failure to Power Up
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY TRANSDUCER SOCKET WAS DAMAGED AND BURNED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045811 ↗MalfunctionApr 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC LITHOTRIPTOR HAD A BROKEN PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045500 ↗MalfunctionApr 23, 2026Activation Failure
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972300 ↗MalfunctionApr 23, 2026Loss of Power
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR EXPERIENCED A LOSS OF POWER. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966971 ↗MalfunctionApr 22, 2026No Device Output
IT WAS REPORTED THE SHOCKPULSE LITHOTRIPSY HANDPIECE HAD AN UNSPECIFIED ERROR THAT OCCURRED AND WILL NOT WORK. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956826 ↗MalfunctionApr 21, 2026Energy Output Problem; Power Problem
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR HAD LOW POWER AND ERROR ON SCREEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945628 ↗MalfunctionApr 21, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER COULD NOT BE INSERTED INTO THE SHOCKPULSE FRONT SOCKET DUE TO DAMAGE TO THE TRANSDUCER PLUG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938444 ↗MalfunctionApr 20, 2026Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER EXHIBITED NO FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24931781 ↗MalfunctionApr 20, 2026Activation Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 24925754 ↗MalfunctionApr 17, 2026Degraded
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR WASN'T WORKING WHEN PLUGGED IN. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915987 ↗MalfunctionApr 16, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY TRANSDUCER EXHIBITED RUST ON THREADED END OF THE TRANSDUCER WHERE THE ULTRASONIC PROBE IS ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905021 ↗MalfunctionApr 16, 2026Suction Failure
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24898345 ↗MalfunctionApr 16, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY HAD NO OUTPUT DUE TO A FAULTY TRANSDUCER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24892701 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171024. One submission often covers many models, so check the product and lot details in each record.
- Z-1494-2026 · Jan 8, 2026 · Open, ClassifiedBrand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generat
- Z-1478-2026 · Nov 14, 2025 · Open, ClassifiedBrand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPuls
- Z-1477-2026 · Nov 14, 2025 · Open, ClassifiedBrand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPuls
- Z-1479-2026 · Nov 14, 2025 · Open, ClassifiedBrand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy
- Z-0452-2026 · Oct 8, 2025 · Open, ClassifiedBrand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electr
- Z-1514-2022 · Jul 7, 2022 · Open, ClassifiedShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Other Lithotriptor, ultrasonic devices
- ShockPulse SPL-SGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls159 reports
- SHOCKPULSE SPL-SRGyrus ACMI, LLC · Lithotriptor, Ultrasonic2 recalls97 reports
- ShockPulse SPL-GGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls10 reports
- Lithotripsy Transducer ShockPulse-SE SPL-TCybersonics Inc · Lithotriptor, Ultrasonic1 recall24 reports
- ShockPulse SPL-FSGyrus ACMI, LLC · Lithotriptor, ultrasonic20 reports
- ShockPulse Lithotripsy Generator SPL-GCybersonics Inc · Lithotriptor, Ultrasonic8 reports
- Lithotripsy System ShockPulse-SE SPL-SCybersonics Inc · Lithotriptor, Ultrasonic7 reports
- Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 11.3 Fr (3.76mm) X 396mm SPL-PD376Cybersonics Inc · Lithotriptor, Ultrasonic6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page