Dislodger, Stone, Flexible
Gastroenterology, Urology · 21 CFR 876.4680
Recent MDR events
315 adverse event reports on file
- Stone ConeJul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-39687
- STONE CONEJul 21, 2026MalfunctionBoston Scientific Corporation2124215-2026-39183
- ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICEJul 7, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00705
- Stone ConeApr 22, 2026MalfunctionBoston Scientific Corporation2124215-2026-21791
- STONE CONEMar 3, 2026MalfunctionBoston Scientific Corporation2124215-2026-11594
- ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICEFeb 5, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00138
- STONE CONEJan 28, 2026InjuryBoston Scientific Corporation2124215-2026-05103
- FLEX-CATCH 4 WIRE NITINOL BASKETJan 2, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00004
- FLEX-CATCH 4 WIRE NITINOL BASKETDec 10, 2025InjuryGyrus Acmi, Inc.3011050570-2025-01439
- STONE CONENov 10, 2025MalfunctionBoston Scientific Corporation2124215-2025-81366
Event type breakdown
Recalls
3 recall events for this product code
- US Endoscopy Group IncTerminatedOct 3, 2012
Endoscopic retrieval device.
When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
Z-0006-2013 · View FDA record ↗ - Scion Cardio-Vascular, Inc.TerminatedFeb 27, 2004
SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
Possible difficulty for the user in opening the stone retrieval basket.
Z-0554-04 · View FDA record ↗ - Scion Cardio-Vascular, Inc.TerminatedFeb 27, 2004
The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other fore
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
Z-0557-04 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Isomedix Operations Inc.
S Plainfield, NJ, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
Steris Tomoe Singapore Pte Ltd
Singapore South West, SG
Isomedix Operations, Inc.
Minneapolis, MN, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Ackermann Instrumente Gmbh
RIETHEIM, WEILHEIM Baden-Wurttemberg, DE
Boston Scientific Corporation
Saint Paul, MN, US
Sterigenics Us Llc
Grand Prairie, TX, US
Venusa De Mexico S. De R.l De C.v
CIUDAD JUAREZ Chihuahua, MX
Boston Scientific Corporation
Marlborough, MA, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Lynx Medical Pennsylvania
ERIE, PA, US
Teleflex Medical Llc
Morrisville, NC, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Innovex Medical Co., Ltd.
Shanghai, CN
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Isomedix Operations Inc.
Northborough, MA, US
Nissha Medical Technologies (ohio), Inc.
Norwalk, OH, US
Epflex Feinwerktechnik Gmbh
DETTINGEN/ERMS Baden-Wurttemberg, DE
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Dornier Medtech America, Inc.
KENNESAW, GA, US
Promepla S.a.m
MONACO Monaco-Ville, MC
510(k) clearances
19 clearances for this product code
- Scion Cardiovascular, Inc.Nov 22, 2000
K001563 · SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
- Boston Scientific CorpApr 2, 1997
K970121 · STONE DISLODGER, BASKET
- Boston Scientific CorpNov 22, 1996
K963750 · RETRIEVAL SNARE
- United States Endoscopy Group, Inc.Oct 4, 1996
K962676 · DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
- Boston Scientific CorpMay 17, 1995
K951309 · STONE DISLODGER, BASKET
- SurgitekJan 11, 1994
K933261 · GRASPING FORCEPS
- Annex Medical, Inc.Jan 7, 1994
K934598 · GRASPING FORCEPS OR RETRIEVAL FORCEPS
- Critikon Company, LLCMay 17, 1993
K921295 · INTRAVENOUS CATHETERS MODIFICATIONS