ShockPulse SPL-FSRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00821925043695), received between Apr 4, 2022 and Apr 15, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Break; Insufficient Device Problem Information

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY FOOTSWITCH CONNECTIONS STRAIN RELIEF AT CONNECTOR BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889401 ↗
• MalfunctionMar 30, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CABLE JACKET WAS OPEN ON THE ULTRASONIC LITHOTRIPTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711539 ↗
• MalfunctionMar 17, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY FOOTSWITCH'S CABLE WAS DEGRADED WITH EXPOSED WIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621101 ↗
• MalfunctionMar 6, 2026Activation Problem

  IT WAS REPORTED THE SHOCKPULSE LITHOTRIPSY FOOTSWITCH WAS NOT WORKING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT /INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531217 ↗
• MalfunctionFeb 23, 2026Activation Failure

  IT WAS REPORTED THE LITHOTRIPSY FOOTSWITCH EXHIBITED SHOCK PLUS FOOT SWITCH NOT RESPONDING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416584 ↗
• MalfunctionJan 6, 2026Material Integrity Problem

  IT WAS REPORTED THE LITHOTRIPSY FOOTSWITCH'S CORD WAS "HANGING TOGETHER BY A THREAD". THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978824 ↗
• MalfunctionNov 19, 2025Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596267 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE PROTECTIVE COATING AROUND THE CONNECTOR CORD WAS BROKEN, RESULTING IN COSMETIC WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572771 ↗
• MalfunctionOct 1, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE SHOCKPULSE LITHOTRIPSY FOOTSWITCH WAS NOT DELIVERING ENOUGH POWER. THE REPORTED MALFUNCTION OCCURRED DURING A THERAPEUTIC VEIN STONES PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343576 ↗
• MalfunctionAug 15, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT, DURING PROCEDURE THE SHOCKPULSE LITHOTRIPSY FOOTSWITCH HAD CONSTANT STATE OF ACTIVATION WHEN THE FOOTSWITCH WAS CONNECTED. THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WAS A FIVE MINUTE PROCEDURAL DELAY BUT NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992038 ↗
• MalfunctionAug 12, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LITHOTRIPSY FOOTSWITCH DEVICE INTERMITTINGLY CUTS OUT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960083 ↗
• MalfunctionAug 12, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR EXPERIENCED INTERMITTENT ACTIVATION. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959662 ↗
• MalfunctionMar 15, 2023Mechanical Problem; Premature Activation; Mechanical Problem; Premature Activation

  OLYMPUS REPRESENTATIVE (REP.) REPORTED WHEN THE NURSE CONNECTED THE FOOTSWITCH BEFORE THE CASE STARTS , THE TRANSDUCER/PROBE KEPT ON GOING EVEN WHEN THE PEDAL WAS RELEASED. ACCORDING TO THE REPORT, THE SURGEON USUALLY USE THE TRANSDUCER TO THE PROCEDURE , HOWEVER, WANTED TO TRY THIS FOOTSWITCH FOR THIS PARTICULAR CASE (THERAPEUTIC UNSPECIFIED PROCEDURE). THE SURGEON THEN USED BUTTONS ON TRANSDUCER. SURGERY WAS A SUCCESS WITH NO DELAY, INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. AFTER THE CASE, THE REP. TRIED THE FOOTWITCH AND STILL THE SAME ISSUE , AS SOON AS IT IS CONNECTED WITHOUT PRESSING THE PEDAL, THE TRANSDUCER WAS "ON". NO HARM WAS REPORTED. NO PATIENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547849 ↗
• MalfunctionDec 16, 2022Device Remains Activated; Device Remains Activated

  ADDITIONAL INFORMATION REPORTED BY THE CUSTOMER STATES THAT THE NAME OF THE PROCEDURE WAS PERCUTANEOUS NEPHROLITHOTRIPSY (PCNL). THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS NOT COMPLETED AS THE PATIENT'S CONDITION WAS NOT GOOD (NOT CAUSED BY THE DEVICE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000357 ↗
• MalfunctionSep 1, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED DURING DELIVERY AND TESTING THE FIELD SERVICE ENGINEER FOUND AN ABNORMAL FUNCTION AFTER CONNECTING THE DEVICE TO THE GENERATOR. ACCORDING TO THE REPORTER, TESTING FOUND UNABLE TO CONTROL THE PEDAL FUNCTION AND THE UNIT AUTO DELIVER THE ENERGY WHEN CONNECTED. THE DEVICE WAS TESTED WITH ANOTHER GENERATOR AND SIMILAR PROBLEMS FOUND. THE ISSUE FOUND DURING INSTALLATION AND NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339604 ↗
• MalfunctionSep 1, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE DEVICE SELF ACTIVATED WHEN CONNECTED TO THE GENERATOR. THE ISSUE FOUND DURING PRE CHECK BEFORE INSTALLATION. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339069 ↗
• MalfunctionJul 6, 2022Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE SHOCK PULSE UNIT WAS AUTOMATICALLY ACTIVATING WHEN THE FOOTSWITCH (SUBJECT DEVICE) WAS CONNECTED TO THE UNIT. THE ISSUE WAS FOUND WHEN PREPARING THE DEVICE FOR USE, NOT DURING ANY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14933849 ↗
• MalfunctionJul 5, 2022Intermittent Continuity; Intermittent Continuity

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE SHOCKPULSE LITHOTRIPSY FOOTSWITCH IMMEDIATELY TURNED ON WHEN PLUGGED INTO THE SHOCKPULSE-SE. THE FOOTSWITCH WAS BEING USED FOR THE FIRST TIME. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914854 ↗
• MalfunctionApr 15, 2022Device Remains Activated; Device Remains Activated

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING INSTALLATION, THE SHOCK PULSE GENERATOR ACTIVATES UPON CONNECTION TO THE DEVICE AND DOES NOT TURN OFF UNTIL THE DEVICE IS DISCONNECTED. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117230 ↗
• MalfunctionApr 4, 2022Device Remains Activated; Device Remains Activated

  AS REPORTED BY THE OLYMPUS TERRITORY MANAGER FOR THIS EVENT, THE DEVICE REMAINED ACTIVE ALL THE TIME. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998832 ↗

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, Classified
  Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generat
• Z-1479-2026 · Nov 14, 2025 · Open, Classified
  Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy
• Z-1477-2026 · Nov 14, 2025 · Open, Classified
  Brand 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-1478-2026 · Nov 14, 2025 · Open, Classified
  Brand 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-0452-2026 · Oct 8, 2025 · Open, Classified
  Brand 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, Classified
  ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S