Bard® Platinum Class™ II Flat Wire Stone Basket 045315Recalls & reported problems
C. R. Bard, Inc. · Bard® Platinum Class™ II Flat Wire Stone Basket · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741066887), received between May 2, 2018 and Jul 9, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Device Inoperable1
- Material Fragmentation1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2020Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DISTAL PORTION OF THE PROTECTIVE SHEATH ON A 3F PLATINUM BASKET BROKEN OFF THE BASKET DURING THE UNCOMPLICATED URETEROSCOPY FOR A DISTAL STONE AND REMOVED THE FOREIGN BODY BY USING THE ANOTHER BASKET.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10253298 ↗MalfunctionMay 2, 2018Device Inoperable; Mechanical Problem; Device Inoperable
IT WAS REPORTED THAT THE STONE BASKET WOULD NOT CLOSE, SO IT WAS NOT USED.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7480366 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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