Bard® Platinum Class™ II Flat Wire Stone Basket 045370Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741066894), received between Apr 25, 2018 and May 14, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Inoperable” (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
- Device Inoperable1
- Difficult to Open or Close1
- Entrapment of Device1
- Material Rupture1
- Positioning Problem1
- Sticking1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Rupture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2018Device Inoperable; Entrapment of Device; Material Rupture; Device Inoperable; Positioning Problem
IT WAS REPORTED THAT DURING THE REMOVAL OF A STONE, THE BASKET WOULD NOT CLOSE AROUND THE STONE AND GOT STUCK IN THE URETHRA. THE NURSE STATED THAT THE BASKET RUPTURED THE URETER AND THE PATIENT REQUIRED ADDITIONAL SURGERY AND HAD A STENT PLACED. PER ADDITIONAL INFORMATION RECEIVED FROM COMPLAINANT. THE ADDITIONAL SURGERY WAS IMMEDIATELY PERFORMED. THERE WERE NO ADDITIONAL COMPLICATIONS. IT IS UNKNOWN THE SIZE OF THE STONE.
Patient problems: No Known Impact Or Consequence To Patient; Rupture
MAUDE report 7511127 ↗InjuryApr 25, 2018Sticking; Difficult to Open or Close
PT UNDERWENT URETEROSCOPY WITH STONE EXTRACTION PROCEDURE. THE MD USED A BASKET TO RETRIEVE THE STONE. THE OPERATING ROOM TECH COULD NOT CLOSE THE BASKET AROUND STATING IT WAS STUCK. THE MD WAS ABLE TO REMOVE THE BASKET, BUT THE URETER WAS DAMAGED IN THE PROCESS.
Patient problems: No Code Available
MAUDE report 7463900 ↗
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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