Dislodger, Stone, Basket, Ureteral, Metal
Gastroenterology, Urology · 21 CFR 876.4680
Recent MDR events
6,079 adverse event reports on file
- NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTORJul 29, 2026MalfunctionCook Inc1820334-2026-00773
- NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTORJul 29, 2026MalfunctionCook Inc1820334-2026-00774
- DAKOTAJul 21, 2026MalfunctionBoston Scientific Corporation2124215-2026-39462
- ZERO TIPJul 20, 2026MalfunctionBoston Scientific Corporation2124215-2026-38173
- MEMORY HARD WIRE BASKETJul 17, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00355
- ZERO TIPJul 16, 2026MalfunctionBoston Scientific Corporation2124215-2026-38227
- ESCAPEJul 16, 2026MalfunctionBoston Scientific Corporation2124215-2026-38245
- NCIRCLE TIPLESS STONE EXTRACTORJul 15, 2026MalfunctionCook Inc1820334-2026-00735
- NCIRCLE TIPLESS STONE EXTRACTORJul 15, 2026MalfunctionCook Inc1820334-2026-00738
- NCIRCLE TIPLESS STONE EXTRACTORJul 15, 2026MalfunctionCook Inc1820334-2026-00739
Event type breakdown
Recalls
10 recall events for this product code
- Wilson-Cook Medical Inc.Open, ClassifiedJul 28, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of b
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Z-2252-2023 · View FDA record ↗ - Wilson-Cook Medical Inc.Open, ClassifiedJul 28, 2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of bi
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Z-2253-2023 · View FDA record ↗ - C.R. Bard, Inc.TerminatedOct 31, 2014
Bard Dimension Stone Basket
The product is non-sterile.
Z-0163-2015 · View FDA record ↗ - Sterilmed IncTerminatedJan 13, 2009
Stone Retrieval Basket Model #': BOS390-105
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0571-2009 · View FDA record ↗ - Boston Scientific CorpTerminatedFeb 8, 2006
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.
The basket wire assembly may detach from the drive wire while in the patient.
Z-0510-06 · View FDA record ↗ - Boston Scientific CorpTerminatedFeb 8, 2006
Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.
The basket wire assembly may detach from the drive wire while in the patient.
Z-0511-06 · View FDA record ↗ - Cardinal HealthTerminatedNov 5, 2004
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corp
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
Z-0179-05 · View FDA record ↗ - C.R. Bard, Inc., Urological DivisionTerminatedJan 9, 2004
Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Product packaging may contain holes compromising sterility.
Z-0314-04 · View FDA record ↗ - C.R. Bard, Inc., Urological DivisionTerminatedJan 9, 2004
Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Product packaging may contain holes compromising sterility.
Z-0315-04 · View FDA record ↗ - Philips North America, LLCOpen, ClassifiedUnknown
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Z-0926-2022 · View FDA record ↗
Registered firms
114 firms currently registered for this product code
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Yangzhou Jiangsu, CN
C.r. Bard, Inc.
Queensbury, NY, US
Boston Scientific Corporation
El Coyol Alajuela, CR
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Auris Health, Inc.
San Jose, CA, US
Voma Ecza Deposu Medikal Urunler San. Tic. A.s.
IZMIR, TR
Cardinal Health P.r. 218, Inc.
ANASCO, PR, US
Jpex Medical Equipment & Supplies, Inc.
Ronkonkoma, NY, US
Synergy Health Ast, Srl
Alajuela, CR
C.r. Bard, Inc.
MADISON, GA, US
Rocamed Sam
MONACO Monaco-Ville, MC
Plasti-med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.
Tuzla Istanbul, TR
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
Ji 'an Jiangxi, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Hunan Endoso Life Technology Co., Ltd
XiangTan Hunan, CN
Suru International Pvt Ltd
DAHANU Maharashtra, IN
American Medical Endoscopy
Doral, FL, US
Coloplast Manufacturing France, Sas
Sarlat la Caneda Cedex Dordogne, FR
Cbr Enterprise Limited
Hong Kong, HK
Scivita Medical Technology Co., Ltd.
suzhou Jiangsu, CN
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Ha2 Medizintechnik Gmbh
Halberstadt Saxony-Anhalt, DE
Endotheia, Inc.
Nashville, TN, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Cook Incorporated
Spencer, IN, US
510(k) clearances
52 clearances for this product code
- Calcula Technologies, Inc.Jul 18, 2019
K190492 · Peralta Stone Removal Catheter
- Ths International, Inc. D/B/A Accordion MedicalSep 19, 2017
K172299 · Accordion Piccolo Stone Management Device
- Percutaneous Systems, Inc.May 16, 2011
K102887 · ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
- Percutaneous Systems, Inc.Nov 13, 2008
K082803 · COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
- Percutaneous Systems, IncorporatedSep 13, 2005
K052048 · ACCORDION
- Sterilmed, Inc.Feb 14, 2002
K012581 · REPROCESSED STONE RETRIEVAL BASKETS
- American Medical Systems, Inc.Aug 29, 1997
K972091 · AMS FOREIGN BODY EXTRATOR
- Comeg EndoscopyMar 19, 1997
K970489 · COMEG ENDOSCOPY GRASPING FORCEPS