SHOCKPULSE SPL-PDBX340Recalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 10.2 Fr (3.40 mm) x 396 mm (3/Pk) · Class 2
All models of SHOCKPULSE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925044234), received between Jul 23, 2025 and Jan 13, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Failure to Deliver Energy1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Material Twisted/Bent
IT WAS REPORTED THE LITHOTRIPTOR, ULTRASONIC PROBE BROKE WHILE BEING USED. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059429 ↗MalfunctionJan 12, 2026Break
IT WAS REPORTED THE ULTRASONIC LITHOTRIPTOR HAD BROKEN PROBE WHILE IN USE. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE AND WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24038031 ↗MalfunctionNov 20, 2025Break; Break
IT WAS REPORTED THAT THE ULTRASONIC LITHOTRIPTOR PROBE BROKE AFTER BEING ACTIVATED FIVE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609247 ↗MalfunctionJul 23, 2025Failure to Deliver Energy; Failure to Deliver Energy
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580206 ↗
Other Lithotriptor, Ultrasonic devices
- ShockPulse SPL-TGyrus ACMI, LLC · Lithotriptor, ultrasonic279 reports
- 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
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.
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