Lithotriptor, Electro-Hydraulic
FDA adverse event reports and recall history for lithotriptor, electro-hydraulic (product code FFK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 438
- Deaths
- 9
- Injuries
- 114
- Malfunctions
- 290
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2020-03-24TerminatedNonconforming Material/Component
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- 2020-03-24TerminatedNonconforming Material/Component
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- 2020-03-24TerminatedNonconforming Material/Component
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- 2009-11-11TerminatedOther
Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.
The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."
- 2007-08-09TerminatedOther
Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray
Sterilization Instructions not adequate for sterilizing.
- 2007-03-30TerminatedOther
Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
Handpiece may become dislodged causing cable damage and possible electric shock.
- 2004-07-20TerminatedOther
ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
Product sterility may be compromised due to the lack of package seal integrity
- 2004-07-20TerminatedOther
ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM
Product sterility may be compromised due to the lack of package seal integrity
- 2004-07-20TerminatedOther
ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM
Product sterility may be compromised due to the lack of package seal integrity
- 2004-07-20TerminatedOther
ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
Product sterility may be compromised due to the lack of package seal integrity
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