Expand 212® Helical Stone Basket 040415Recalls & reported problems
C. R. Bard, Inc. · Expand 212® Helical Stone Basket · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741076473), received between Oct 2, 2017 and Apr 29, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (2 reports).
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
- Difficult to Open or Close2
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE HELICAL BASKET WAS BENT HENCE, IT COULD NOT BE CLOSED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11748494 ↗MalfunctionOct 3, 2018Difficult to Open or Close
IT WAS REPORTED THAT THE HAND PIECE ON THE STONE BASKET WOULD NOT OPEN OR CLOSE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7930157 ↗MalfunctionOct 2, 2017Difficult to Open or Close
IT WAS REPORTED THAT THE STONE BASKET WOULD NOT CLOSE DURING THE PROCEDURE. THE COMPLAINANT REPORTED THAT THE STONE BASKET WAS REMOVED WITHOUT COMPLICATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6907211 ↗
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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