Bard® Dimension® Stone Basket 042313Recalls & reported problems
C. R. Bard, Inc. · Bard® Dimension® Stone Basket · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741066818), received between Jun 28, 2018 and Jan 9, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
- Bent1
- Break1
- Difficult to Open or Close1
- Retraction Problem1
Patient problems
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE STONE BASKET BROKE IN THE MIDDLE OF THE SURGERY. PER FOLLOW UP VIA PHONE ON (B)(6) 2025. THE PATIENT WAS NOT IMPACTED. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES TO THE BROKEN BASKET. THERE WAS NO PHOTO TO SUPPLY BUT THEY DID SEND THE BASKET AND PIECES ALONG WITH THE PAPERWORK. THE SURGEON WAS ATTEMPTING TO RETRIEVE THE SPECIMEN, WHILE THE BASKET WAS INSIDE THE PATIENT A PIECE BROKE OFF. ALL PIECES RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21112160 ↗InjuryDec 10, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN THE STONE BASKET WAS WITHDRAWN FROM THE RENAL PELVIS INTO THE URETER, THE BASKET WAS TORN OFF AND REMAINED IN THE URETER. ACCORDING TO THE HEALTH CARE WORKER THE BASKET COULD ONLY BE REMOVED THROUGH OPEN SURGERY. THE INITIAL PROCEDURE HAS BEEN CANCELED. PER FOLLOW UP INFORMATION RECEIVED ON 29NOV2021, ACCORDING TO THE PHYSICIAN THE URETER WAS TORN OFF DURING THE PROCEDURE. THE PATIENT WAS SUCCESSFULLY OPERATED ON (B)(6) 2021. THE REMAINDER OF THE STONE BASKET WAS RECOVERED, AND THE URETER WAS REPLANTED.
Patient problems: Foreign Body In Patient
MAUDE report 12981416 ↗MalfunctionAug 6, 2018Retraction Problem; Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE STONE BASKET DID NOT RETRACT INTO THE SHEATH.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7753399 ↗MalfunctionJun 28, 2018Bent; Break
IT WAS REPORTED THAT UPON OPENING THE STONE BASKET DURING PRE-TEST, ONE OF THE WIRES BENT AND BROKE. THE STAFF RETRIEVED A REPLACEMENT STONE BASKET.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7647974 ↗
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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