Bard® Platinum Class™ II Flat Wire Stone Basket 045215Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741066863), received between Jul 10, 2017 and Feb 26, 2018 — classified as 1 injury, 1 malfunction.
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 Operates Differently Than Expected1
- Material Frayed1
- Retraction Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2018Retraction Problem; Device Operates Differently Than Expected
IT WAS REPORTED THAT WHILE USING A FLAT WIRE STONE BASKET, WITHIN A PATIENT, THE BASKET DISAPPEARED. AN EXHAUSTIVE SEARCH WAS UNDERTAKEN TO DETERMINE THE LOCATION OF THE BASKET, HOWEVER, IT WAS NOT RECOVERED. IT WAS NOTED THAT THERE MAY BE A CHANCE THAT THE BASKET RETRACTED WITHIN THE SHEATH OF THE DEVICE, HOWEVER, THAT COULD NOT BE CONFIRMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7297654 ↗MalfunctionJul 10, 2017Break; Material Frayed
IT WAS REPORTED THAT AFTER 1- 2 PASSES, THE BASKET FRAYED AND BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6699923 ↗
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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