Lithotriptor, Biliary Mechanical
Gastroenterology, Urology · 21 CFR 876.4500
Recent MDR events
2,875 adverse event reports on file
- Trapezoid RXJul 31, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03119
- Trapezoid RXJul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03093
- Single Use Mechanical Lithotriptor VJul 30, 2026InjuryAomori Olympus Co., Ltd.9614641-2026-00795
- Trapezoid RXJul 28, 2026InjuryBoston Scientific Corporation3005099803-2026-03054
- Trapezoid RXJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03056
- Trapezoid RXJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03063
- Trapezoid RXJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03066
- Single Use Mechanical Lithotriptor VJul 28, 2026MalfunctionAomori Olympus Co., Ltd.9614641-2026-00786
- Single Use Mechanical Lithotriptor VJul 28, 2026MalfunctionAomori Olympus Co., Ltd.9614641-2026-00787
- Trapezoid RXJul 27, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03013
Event type breakdown
Recalls
7 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedJan 16, 2025
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30.
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Z-0962-2025 · View FDA record ↗ - Olympus America Inc.TerminatedOct 31, 2007
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
Z-0105-2008 · View FDA record ↗ - Olympus America Inc.TerminatedOct 31, 2007
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
Z-0106-2008 · View FDA record ↗ - Olympus America Inc.TerminatedOct 31, 2007
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
Z-0107-2008 · View FDA record ↗ - Olympus America Inc.TerminatedOct 31, 2007
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
Z-0108-2008 · View FDA record ↗ - Aomori Olympus Co., Ltd.TerminatedUnknown
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.
Z-1067-2021 · View FDA record ↗ - Aomori Olympus Co., Ltd.TerminatedUnknown
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.
Z-1068-2021 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Boston Scientific Corporation
SPENCER, IN, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Henke-sass Wolf, Gmbh.
TUTTLINGEN Baden-Wurttemberg, DE
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Boston Scientific Corporation
Marlborough, MA, US
Aomori Olympus Co., Ltd. Kuroishi Site
KUROISHI-SHI Aomori, JP
Amnotec International Medical Gmbh
Neuhausen ob Eck Baden-Wurttemberg, DE
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Boston Scientific Corporation
Coventry, RI, US
Boston Scientific Limited
GALWAY, IE
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Quasar Medical Tecate, S.a. De C.v
Tecate Baja California, MX
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Synergy Health Ast, Srl
Alajuela, CR
Cook Incorporated
ELLETTSVILLE, IN, US
Aomori Olympus Co., Ltd. Hirosaki Site
Hirosaki-shi Aomori, JP
Wilson-cook Medical Inc.
Winston Salem, NC, US
American Medical Endoscopy
Doral, FL, US
510(k) clearances
11 clearances for this product code
- Boston Scientific CorpMar 12, 2004
K040447 · TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
- Wilson-Cook Medical, Inc.May 4, 2001
K011178 · WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
- Boston Scientific CorpJan 24, 1997
K964937 · A LITHOTRIPTER-COMPATIBLE BASKET
- Medi-Globe Corp.Nov 22, 1994
K942544 · GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS
- Boston Scientific CorpAug 29, 1994
K943191 · MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
- Baxter Healthcare CorpDec 17, 1991
K905552 · LAPAROLITH
- Northgate Technologies, Inc.Oct 23, 1991
K911364 · SPOON FORCEPS, 11MM
- United States Endoscopy Group, Inc.Aug 14, 1991
K911477 · LAPAROSCOPIC BASKET FLEXIBLE AND RIGID