SHOCKPULSE SPL-SRRecalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY SYSTEM SHOCKPULSE-SE · Class 2
All models of SHOCKPULSE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Gyrus ACMI Shockpulse ultrasonic lithotripter has 97 adverse event reports describing parts breaking, energy or output problems, and activation or power-up failures, with no deaths and 1 injury. It has 2 open recalls: one for a mis-wired component that may add noise and reduce reliability, and one for a generator staying in a blinking phase that may damage the transducer plug or generator receptacle. Reports dropped from 48 to 31 in the last 12 months.
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
- 97
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00821925043824), received between Mar 18, 2024 and Sep 25, 2026 — classified as 1 injury, 96 malfunctions.
The most frequently reported specific device problem is “Break” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
- 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-1477-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break13
- Energy Output Problem13
- Communication or Transmission Problem11
- Output Problem10
- Activation Problem9
- Failure to Power Up7
- Activation Failure6
- Loose or Intermittent Connection4
Patient problems
- No Clinical Signs, Symptoms or Conditions96
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903647 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
It was reported the Lithotripsy gave continuous check probe error. The issue occurred during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770947 ↗MalfunctionSep 10, 2026Loss of Power; Unexpected Shutdown; No Visual Prompts/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718433 ↗MalfunctionSep 9, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701797 ↗MalfunctionSep 9, 2026Loose or Intermittent Connection; No Visual Prompts/Feedback
The customer returned the LITHOTRIPSY SYSTEM for a separate issue. During the initial evaluation of the returned device, Due to poor contact of transducer socket, press the "S" button on the transducer and hold it, "Standard Power" light is not illuminating green was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696044 ↗MalfunctionSep 1, 2026No Device Output; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535915 ↗MalfunctionMar 17, 2026Energy Output Problem; Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY EXHIBITED SMOKING AND BURN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621880 ↗MalfunctionMar 16, 2026Unexpected Shutdown
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR STOPPED WORKING. 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 24611062 ↗MalfunctionMar 13, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY FOOT WAS LOOSENED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591178 ↗MalfunctionMar 5, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523570 ↗MalfunctionMar 5, 2026Flare or Flash
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521505 ↗MalfunctionFeb 26, 2026No Apparent Adverse Event
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM DID NOT EMIT A "NO PROBE ERROR" WHEN WITHOUT A PROBE; IT WAS FURTHER REPORTED THAT THE TRANSDUCER RECEPTACLE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456918 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR CONNECTOR¿S PINS ARE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369892 ↗MalfunctionFeb 10, 2026Failure to Deliver Energy
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPSY SYSTEM EXHIBITED A FAULT IN THE CONTROL UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309067 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR HAD A DEFECTIVE PANEL. THE ISSUE OCCURRED DURING SERVICE / MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292089 ↗MalfunctionFeb 3, 2026Blocked Connection; Activation Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRANSDUCER RECEPTACLE WAS FOUND TO BE BURNT; ALSO, AN ERROR APPEARED WHEN CONNECTING THE FOOT SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247981 ↗MalfunctionJan 13, 2026Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053848 ↗MalfunctionJan 9, 2026Overheating of Device
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020610 ↗MalfunctionJan 7, 2026Communication or Transmission Problem
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR HAD A PROBE ERROR. 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 23990452 ↗MalfunctionJan 2, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LITHOTRIPTOR, ULTRASONIC DISPLAYED A PROBE ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944251 ↗MalfunctionDec 30, 2025Break; Deformation Due to Compressive Stress; Communication or Transmission Problem; Break; Deformation Due to Compressive Stress; Communication or Transmission Problem
IT WAS REPORTED THE LITHOTRIPSY SYSTEM EXHIBITED AN UNSPECIFIED ERROR DURING USE ON AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920929 ↗MalfunctionDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE LITHOTRIPSY TRANSDUCER WAS NOT WORKING. THIS EVENT OCCURRED DURING A CAT-1 PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23864242 ↗MalfunctionDec 10, 2025Failure to Power Up; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770934 ↗MalfunctionDec 8, 2025Activation Problem; Activation Problem
IT WAS REPORTED THE LITHOTRIPSY SYSTEM EXHIBITED "ERROR" AND "CHECK PROBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23751808 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THE LITHOTRIPTOR, ULTRASONIC RECEPTACLES SOCKET BURNT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692695 ↗
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-SGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls159 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 · each recall links to the FDA recall notice
- 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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