Lithotriptor, Biliary Mechanical
FDA adverse event reports and recall history for lithotriptor, biliary mechanical (product code LQC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,845
- Deaths
- 12
- Injuries
- 653
- Malfunctions
- 2,158
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
- 2025-01-16Open, ClassifiedUnder Investigation by firm
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Potential for distal tip tearing of the Mechanical Lithotriptor V.
- 2007-10-31TerminatedProcess control
Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- 2007-10-31TerminatedProcess control
Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America, Inc.
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- 2007-10-31TerminatedProcess control
Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America, Inc.
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- 2007-10-31TerminatedProcess control
Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
- TerminatedUnder Investigation by firm
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- TerminatedUnder Investigation by firm
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
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