Gyrus ACMI E-9FRecalls & reported problems
Gyrus ACMI, LLC · ELECTROHYDRAULIC LITHOTRIPSY PROBE 9 FR (3.0 mm) X 60 cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925036383), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K980492); 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
OLYMPUS RECEIVED MEDWATCH REPORT MW5118174 WHICH STATED THAT A DURING BLADDER STONE LITHOTRIPSY, THE PHYSICIAN IDENTIFIED A SMALL PIECE OF TIP FROM THIS ELECTROHYDRAULIC LITHOTRIPSY PROBE ERODED. BLADDER IRRIGATION WAS DONE TO REMOVE THE PIECE OF TIP. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS INSPECTED BEFORE USE AND WAS INTACT. THE PATIENT WAS DISCHARGED HOME. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17248551 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K980492. One submission often covers many models, so check the product and lot details in each record.
- Z-0928-04 · Apr 30, 2004 · TerminatedACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
- Z-0927-04 · Apr 30, 2004 · TerminatedACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM
- Z-0926-04 · Apr 30, 2004 · TerminatedACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM
- Z-0925-04 · Apr 30, 2004 · TerminatedACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
Other Lithotriptor, electro-hydraulic devices
- Lithotripsy Probe 1.9FR 375cm DS M00546620Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall1 death19 reports
- Autolith Touch M005466800Northgate Technologies Inc. · Lithotriptor, Electro-Hydraulic1 recall12 reports
- Ultrasound Probe M0068407170Boston Scientific Corporation · Lithotriptor, electro-hydraulic15 reports
- CyberWand USL Ultrasonic Lithotripsy System CW-USLSACybersonics Inc · Lithotriptor, Electro-Hydraulic4 reports
- Ultrasound Probe M0068407160Boston Scientific Corporation · Lithotriptor, electro-hydraulic3 reports
- CyberWand USL Advanced Transducer CW-USLTACybersonics Inc · Lithotriptor, Electro-Hydraulic2 reports
- StoneBreaker G52605Cook Incorporated · Lithotriptor, electro-hydraulic1 report
- CyberWand USL Foot Switch CW-USLFSCybersonics Inc · Lithotriptor, Electro-Hydraulic1 report
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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