SHOCKPULSE SPL-PDBX150Recalls & reported problems
Gyrus ACMI, LLC · LITHOTRIPSY PROBE, STERILE SINGLE USE, ShockPulse-SE, 4.5 Fr (1.50 mm) x 564 mm (3/PK) · Class 2
All models of SHOCKPULSE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925044210), received between Mar 4, 2026 and Mar 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
6 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. 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
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507537 ↗MalfunctionMar 4, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Insufficient Information
MAUDE report 24507449 ↗
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-1494-2026 · Jan 8, 2026 · Open, ClassifiedBrand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generat
- Z-1477-2026 · Nov 14, 2025 · Open, ClassifiedBrand 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-1479-2026 · Nov 14, 2025 · Open, ClassifiedBrand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy
- Z-1478-2026 · Nov 14, 2025 · Open, ClassifiedBrand 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, ClassifiedBrand 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, ClassifiedShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
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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