ShockPulse SPL-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821925044203), received between Oct 23, 2023 and Jan 23, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 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.

Recalls naming this device

1. Jan 8, 2026Open, 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. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

   Z-1494-2026 · Root cause: Device Design · FDA record ↗

2. 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-1479-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158345 ↗
• MalfunctionDec 9, 2025Power Problem; Power Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757936 ↗
• MalfunctionNov 6, 2025Melted; Melted

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485517 ↗
• MalfunctionSep 12, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE'S POWER-ON LIGHT WAS NOT FUNCTIONING. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039066 ↗
• MalfunctionSep 2, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD INAPPROPRIATE OUTPUT. THE ISSUE WAS FOUND DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946498 ↗
• MalfunctionAug 27, 2025Melted; Melted

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A SOCKET CONNECTOR BURN. THE ISSUE OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903176 ↗
• MalfunctionAug 4, 2025Activation Problem; Activation Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701509 ↗
• MalfunctionJan 2, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE SUBJECT DEVICE SHOWED AN ERROR ON PANEL AND WOULD NOT WORK. THE ISSUE WAS FOUND DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21059932 ↗
• MalfunctionDec 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THE SHOCKPULSE LITHOTRIPSY GENERATOR EXPERIENCED THAT WHEN PRESSING THE STANDARD BUTTON ON THE TRANSDUCER, THE STATUS ON THE FRONT OF THE MACHINE IS DISPLAYED AT HIGH. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029701 ↗
• MalfunctionOct 23, 2023Break; Break

  THE CUSTOMER REPORTED THAT DURING A LITHOTRIPSY PROCEDURE THE DEVICE STOPPED WORKING AND COULDN¿T BE ACTIVATED BY THE PEDAL. THE PEDAL WAS DISCONNECTED TO MANUALLY ACTIVATE THROUGH THE TRANSDUCER AND THE SAME ERROR OCCURRED. AN ERROR WITH AN X APPEARED. THEN IT WAS NOTICED THAT THE TRANSDUCER LOOKED LIKE IT WAS BURNED AND BROKEN INSIDE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY REPORTED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990971 ↗

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-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