SHOCKPULSE SPL-PDBX376Recalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm (3/PK) · Class 2
Data updated Oct 13, 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 00821925044241), received between Nov 12, 2024 and Apr 21, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Corroded” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded3
- Break2
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.
MalfunctionApr 21, 2026Break; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, ULTRASONIC LITHOTRIPTORS PROBE SHEATH BROKEN IN HALF AND THE METAL THREADS ON THE DEVICE IS RUSTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24937319 ↗MalfunctionOct 15, 2025Corroded; Corroded
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297989 ↗MalfunctionJun 30, 2025Break
DURING PROCEDURE WHILE THE LITHOTRIPTER WAS ACTIVE THE PROBE BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22352631 ↗MalfunctionNov 12, 2024Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PROBE GOT STUCK IN TRANSDUCER DUE TO HEAVY RUST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667176 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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