Bard® SkyLite™ Tipless Nitinol Stone Basket 041900Recalls & reported problems
C. R. Bard, Inc. · 1.9Fr 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
Quick summary
This Bard SkyLite stone basket is a thin wire basket used to grab and remove stones from the ureter, the tube between the kidney and bladder. Its 78 reports, with no deaths and 7 injuries, mostly describe malfunctions (71 reports): wire pieces breaking off, baskets that would not open or close, and baskets that broke during use. Some reports mention pieces left in the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00801741111518), received between May 26, 2017 and Feb 23, 2026 — classified as 7 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (27 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 Fragmentation27
- Difficult to Open or Close18
- Break12
- Component Misassembled5
- Disconnection5
- Device Contamination with Chemical or Other Material4
- Accessory Incompatible3
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient18
- Foreign Body In Patient10
- No Patient Involvement3
- No Code Available2
- No Information2
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Material Fragmentation
IT WAS REPORTED THAT AFTER GRIPPING THE STONE TWICE WITH THE BASKET, IT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416378 ↗MalfunctionFeb 20, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING USE THE HANDLE OF NITINOL BASKET GOT STUCK WHEN SLIDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24406088 ↗MalfunctionFeb 18, 2026Device Dislodged or Dislocated; Component Misassembled
IT WAS REPORTED THAT DURING USE (THIS EVENT WAS DISCOVERED WHEN USED IN AN OPERATION) NITINOL BASKET EXPERIENCED A MALFUNCTION IN WHICH THE PRODUCT DISLOCATED AS SOON AS IT WAS TRIED TO BE USED, AND LOT NUMBER OF THE APPROPRIATE PRODUCT WAS NGKU0740. IT IS UNKNOWN WHETHER IT WAS NOTICED BEFORE INSERTION INTO THE PATIENT OR WHEN IT WAS INSERTED ONCE AND DILATED IN THE URETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381800 ↗MalfunctionDec 29, 2025Flaked; Flaked
IT WAS REPORTED THAT THE VISIBLUE COATING ON THE TIP OF THE STONE BASKET WAS PEELED OFF DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916980 ↗MalfunctionDec 5, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING USE THE NITINOL BASKET SHAFT NEAR THE TIP END POINT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728602 ↗MalfunctionOct 9, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE STONE BASKET WIRE WAS WRAPPED AROUND THE OTHERS CAUSING THE BASKET TO DEPLOY IMPROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23255059 ↗MalfunctionOct 1, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THIS OCCURRED DURING SURGERY; UNABLE TO CLOSE THE STONE BASKET PROPERLY, SO USE WAS DISCONTINUED, AND A NEW BASKET WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23192114 ↗MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE INTRAOPERATIVE STONE RETRIEVAL PROCESS, ONE WIRE OF THE RETRIEVAL STONE BASKET WAS SNAPPED, NECESSITATING THE REPLACEMENT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064619 ↗MalfunctionAug 19, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE HANDLE OF THE STONE BASKET STOPPED MOVING BACK AND FORTH, AND THE BASKET COULD NO LONGER BE OPENED OR CLOSED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840532 ↗MalfunctionAug 7, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT NITINOL STONE BASKET HANDLE LEVER WAS NOT MOVING PROPERLY DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738617 ↗MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT A HEAVY SKYLITE USER NOTICED THAT THE LEVER WAS STIFF OF THE NITINOL STONE BASKET DURING USE AND DECIDED TO STOP USING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470803 ↗MalfunctionMar 19, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE STONE BASKET DID NOT OPEN OR CLOSE, STAYS OPEN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 04MAR2025, STATED THAT THERE WAS PATIENT INVOLVEMENT BUT NO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21641633 ↗InjuryFeb 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT PART OF THE SKYLITE STONE BASKET WIRE REMAINS INSIDE THE BODY. THEY RECEIVED AN INQUIRY AS TO WHETHER AN MRI WAS POSSIBLE WITH THE SKYLIGHT WIRE STILL INSIDE THE BODY, AND THEY WERE MADE AWARE OF THE FACT THAT IT WAS STILL INSIDE THE BODY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10FEB2025, STATED THAT THE SKYLITE STONE BASKET BROKEN WAS UNKNOWN AND IT WAS UNKNOWN HOW WAS THE SKYLITE STONE BASKET WIRE REMAINED INSIDE THE BODY REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 21410767 ↗MalfunctionOct 17, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE BASKET WAS BROKE DURING THE USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472708 ↗MalfunctionOct 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE FINAL PACKAGING OF NITINOL STONE BASKET HAD AIR LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417009 ↗MalfunctionOct 8, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IMMEDIATELY AFTER OPERATING THE NITINOL STONE BASKET CATHETER TO CAPTURE THE STONE, THE HANDLE PART CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397918 ↗MalfunctionSep 6, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT WHEN PULLED THE LEVER, IT FELT GETTING STUCK AND MAKING IT DIFFICULT TO OPEN THE NITINOL BASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157899 ↗InjurySep 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THEY HAD RECEIVED THE TECHNOVIGILANCE NOTIFICATION REPORTED BY NURSE AND HAVING THE JUSTIFICATION OF THE SURGEON REGARDING THE BASKET THAT PRESENTED THE TECHNICAL COMPLAINT DURING THE PROCEDURE OF THE PATIENT ON (B)(6) 2024 SURGICAL BLOCK OF HOSPITAL. IT WAS NECESSARY TO USE ANOTHER UNIT TO CONTINUE THE PROCEDURE. IT WAS NOT POSSIBLE TO STORE THE PRODUCT AS IT WAS CONTAMINATED. PER ADDITIONAL INFORMATION RECEIVED ON 17APR2024, STATED THAT DURING THE LASER URETEROLITHOTRIPSY PROCEDURE, THE BASKET DISINTEGRATED SO THAT IT DID NOT PERFORM ITS FUNCTION. A METAL FRAGMENT OF THE BASKET MATERIAL REMAINS ON THE FLOOR OF THE URETER. FOR THIS REASON, A NEW BASKET WAS USED, AND ALL FRAGMENTS WERE REMOVED SUCCESSFULLY FROM THE URETER.
Patient problems: Foreign Body In Patient
MAUDE report 20126484 ↗MalfunctionAug 13, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE SKYLITE BASKET HANDLE MOVEMENT IS STIFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19971826 ↗MalfunctionAug 6, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT WIRE OF THE SKYLITE STONE BASKET DID NOT MOVE WHEN WIRE WAS OPENED OR CLOSED BY STEERING WHEEL OPERATION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 25JULY2024, CUSTOMER CONFIRMED THAT NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19920825 ↗InjuryJul 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT MIDDLE-AGED MALE WAS HAVING A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, BILATERAL URETEROSCOPY, AND BILATERAL STONE BASKETING AS AN IN-PATIENT. THE UROLOGIST WAS USING THE URETERAL STONE BASKET RETRIEVAL INSTRUMENT TO REMOVE A STONE FROM THE LEFT URETER. THE INSTRUMENT BROKE INSIDE THE URETER. THE UROLOGIST THEN USED A NON-DISPOSABLE ALLIGATOR FORCEPS TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT¿S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 19721514 ↗MalfunctionJun 25, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE GRIP OF THE STONE MESH WAS NOT EASY TO PUSH. THE STONE NET WAS NOT EASY TO PUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19604471 ↗MalfunctionJun 19, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE NITINOL STONE BASKET HANDLE CAME OFF WHEN THEY OPENED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566321 ↗MalfunctionJun 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT WHEN OPENING AND CLOSING THE STONE BASKET THE CUSTOMER PULLED THE HANDLE, IT MADE A SQUEAKING NOISE AND WAS DIFFICULT TO OPERATE. WHEN THE USER TRIED ANOTHER NEW PRODUCT, THERE WERE NO PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509225 ↗MalfunctionMay 2, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE LITHOTOMY PROCEDURE, THE SKYLITE BASKET WAS BROKEN WITH THE LASER FIBER DURING FRAGMENTATION. THE LASER FIBER HIT THE BASKET HANDLE DURING FRAGMENTATION. THE DEVICE WAS REPLACED WITH ANOTHER BASKET. THERE WAS NO REPORTED PATIENT INJURY. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 18APR2024, THERE WAS NO HARM TO THE PATIENT. THE BASKET WAS BROKEN DUE TO THE INCIDENT WITH THE LASER FIBER SHOT. IT DAMAGED THE MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19229108 ↗
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
- NGage G48295Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL74 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