ShockPulse SPL-SRecalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY SYSTEM ShockPulse-SE · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This ShockPulse lithotripsy system is an ultrasonic lithotripter used to break up stones. Of its 163 adverse event reports, 157 are malfunctions and 6 are injuries, with no deaths. Many describe broken parts, lost output, and power problems. Two open recalls name this device: one over a generator that does not recognize its transducer, and one over a mis-wired part.
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
- 159
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 00821925044197), received between Dec 9, 2020 and Sep 29, 2026 — classified as 6 injuries, 153 malfunctions.
The most frequently reported specific device problem is “Break” (33 reports).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K142428); 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.
Reports received per month
Recalls naming this device
- Nov 14, 2025Open, Classified
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Z-1478-2026 · Root cause: Device Design · FDA record ↗
- Jul 7, 2022Open, Classified
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
Z-1514-2022 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Break33
- Output Problem19
- Communication or Transmission Problem12
- Power Problem11
- Connection Problem10
- No Device Output10
- Defective Device8
- Energy Output Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- No Patient Involvement11
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
- Pneumothorax1
- Sepsis1
- Unspecified Respiratory Problem1
Recent adverse event reports
The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Output below Specifications
It was reported that the shock pulse lithotripsy system exhibited poor power output. The issue occurred during a therapeutic procedure that was delayed for less than 30 minutes under sedation. The procedure was subsequently completed using the same device. No reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935175 ↗MalfunctionSep 22, 2026Activation Problem
The customer returned the LITHOTRIPSY SYSTEM to the service center for a separate issue. During the device analysis, the investigator indicated that a failed probe test due to faulty control board was found. It was determined that the control board needed to be replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854807 ↗MalfunctionSep 11, 2026Activation Failure; Complete Loss of Power
It was reported the Lithotripsy was not powering on. The issue occurred during setup. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732694 ↗MalfunctionSep 8, 2026Communication or Transmission Problem; Complete Loss of Power
It was reported the lithotripsy system stopped working and produced an error. This was further clarified to state that a "broken scope" error was produced when the foot pedal was used. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670237 ↗MalfunctionSep 1, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548775 ↗MalfunctionAug 12, 2026Thermal Decomposition of Device; Electrical /Electronic Property Problem
The customer returned the LITHOTRIPSY SYSTEM, which is an Olympus asset with no reported complaint. During the evaluation of the device, faulty transducer receptacles unit at front with burn marks inside was observed. The investigator indicated that the most likely cause of the faulty transducer receptacles with burn marks was due to component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224410 ↗MalfunctionMay 13, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM FAILED AN OUTPUT TEST DUE TO A FAULTY TRANSDUCER RECEPTACLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165309 ↗MalfunctionMay 8, 2026Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC LITHOTRIPTOR HAD BENT PINS ON THE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125746 ↗MalfunctionApr 15, 2026Break; Key or Button Unresponsive/not Working
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE LITHOTRIPSY SYSTEM WAS NOT WORKING WITH THE FOOTSWITCH OR PROBE AND HAD A BROKEN PIN ON THE TRANSDUCER CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888411 ↗MalfunctionApr 15, 2026Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE LITHOTRIPSY SYSTEM HAD ISSUES WITH ISSUES WITH POWER OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886544 ↗MalfunctionApr 15, 2026Power Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY ELECTRICAL SYSTEM HAD INTERMITTENT LOSS OF ENERGY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884308 ↗MalfunctionApr 14, 2026Output Problem; Positioning Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM WAS NOT GENERATING ENERGY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877592 ↗MalfunctionApr 14, 2026Power Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY HAD A HIGH POWER: 60 WATTS, A LOW POWER: 37 WATTS, AND POWER WATTS DIFFERENCE: 23 WATTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874236 ↗MalfunctionApr 6, 2026Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24795497 ↗MalfunctionApr 2, 2026Crack
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766889 ↗MalfunctionMar 30, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY EXHIBITED FAILED PROBE TEST AND NO OUTPUT DUE TO FAULTY CONTROL BOARD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736981 ↗MalfunctionMar 26, 2026No Device Output
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC LITHOTRIPTOR'S POWER ON TEST THE POWER ENTRY MODULE IS FAULTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699698 ↗MalfunctionMar 24, 2026Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM EXHIBITED AN ENERGY OUTPUT PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677234 ↗MalfunctionMar 19, 2026Mechanical Problem
IT WAS REPORTED THE LITHOTRIPSY SYSTEM GENERATOR EXHIBITED AN ¿ERROR¿ SIGNAL AFTER WORKING AT THE BEGINNING OF THE CASE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641334 ↗MalfunctionMar 18, 2026Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY SYSTEM RED ERROR LIGHT, AND THE RED CHECK PROBE LIGHTS DID NOT ACTIVATE AFTER FOOTSWITCH WAS HELD DOWN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630838 ↗MalfunctionMar 10, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565484 ↗MalfunctionMar 9, 2026Degraded; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM EXHIBITED AN OUTPUT FAIL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548251 ↗MalfunctionFeb 27, 2026Suction Problem; Power Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474612 ↗MalfunctionFeb 27, 2026Energy Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470963 ↗MalfunctionFeb 27, 2026Energy Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470075 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142428. One submission often covers many models, so check the product and lot details in each record.
- Z-2197-2020 · Apr 23, 2020 · TerminatedOLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Other Lithotriptor, ultrasonic devices
- ShockPulse SPL-TGyrus ACMI, LLC · Lithotriptor, ultrasonic279 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.