Bard® SkyLite™ Tipless Nitinol Stone Basket 043000Recalls & reported problems
C. R. Bard, Inc. · 3.0Fr Nitinol Tipless Basket · Class 2
All models of Bard SkyLite Tipless Nitinol Stone Basket (3)
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 00801741111501), received between Jul 5, 2023 and Apr 30, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN NURSE OPENED UP SKYLITE BASKET AND THE HANDLE POPPED OFF, SO THEY WERE NOT ABLE TO USE THE BASKET AND NEEDED TO OPEN A NEW BASKET DUE TO HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212057 ↗MalfunctionJul 5, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT "NO, USER WAS NOT ABLE TO SUCCESSFULLY REMOVE THE RENAL STONE" WHILE USING A SKYLITE STONE BASKET BECAUSE OF "SIZE LITHIASIS SEVERAL FRAGMENTS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17254333 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page