SHOCKPULSE SPL-PR150Recalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 4.5 Fr (1.50 mm) x 564 mm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925043787), received between Oct 29, 2025 and Feb 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Detachment of Device or Device Component; Output Problem
IT WAS REPORTED THE SHOCKPULSE LITHOTRIPSY WHEN USING THE PROBE FOR LITHOTRIPSY OF A CONCREMENT OF THE LOWER URETER, AFTER THE THIRD PRESSING AND ACTIVATING THE PEDAL, THE PROBE STOPPED WORKING AND UPON INSPECTION THE DISTAL PART OF THE PROBE SEPARATED FROM THE PART THAT SHOULD BE ON THE INTRODUCER. THE ISSUE OCCURRED DURING A THERAPEUTIC LITHOTRIPSY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413603 ↗MalfunctionDec 23, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SHOCKPULSE LITHOTRIPSY PROBE EXHIBITED THE THREAD WAS STUCK IN THE HAND PIECE AND RUST WAS DETECTED AT THE PROXIMAL END SIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23882692 ↗MalfunctionOct 29, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418523 ↗
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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.