Dislodger, Stone, Basket, Ureteral, Metal
FDA adverse event reports and recall history for dislodger, stone, basket, ureteral, metal (product code FFL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,059
- Deaths
- 5
- Injuries
- 1,000
- Malfunctions
- 5,007
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
- 2023-07-28Open, ClassifiedProcess control
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
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).
- 2023-07-28Open, ClassifiedProcess control
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
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).
- 2014-10-31TerminatedRelease of Material/Component prior to receiving test results
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
The product is non-sterile.
- 2009-01-13TerminatedPackaging process control
Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.
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
- 2006-02-08TerminatedOther
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.
- 2006-02-08TerminatedOther
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.
- 2004-11-05TerminatedOther
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
- 2004-01-09TerminatedOther
Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Product packaging may contain holes compromising sterility.
- 2004-01-09TerminatedOther
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.
- Open, ClassifiedDevice Design
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
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