Bard® SkyLite™ Tipless Nitinol Stone Basket 042400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741111495), received between Aug 14, 2019 and Oct 24, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT STONE BASKET DEPLOYED IMPROPERLY WHICH LED TO A STONE BECAME STUCK IN THE BASKET RESULTING IN THE NITINOL TIPLESS BASKET NEEDED TO BE DISASSEMBLED WHILE IN THE PATIENT. WASTE OF TIME AND POTENTIAL HAZARD TO PATIENT IF IT WAS LEFT UNRESOLVED. PER EMAIL RESPONSE RECEIVED ON 10DEC2025. IT WAS REPORTED THAT NO PHYSICAL SAMPLE IS AVAILABLE. NO LOT NUMBER WAS PROVIDED. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380214 ↗
• MalfunctionJan 31, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THEY FOUND SOME HAIRS IN THE NITINOL BASKET. SO, THEY COULD NOT USE IT BECAUSE OF INFECTION CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282472 ↗
• MalfunctionNov 5, 2024Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS HAIR IN NITINOL TIPLESS BASKET. IT CANNOT BE USED BECAUSE OF CONCERNS ABOUT INFECTION, SO IT WAS SENT AS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609964 ↗
• MalfunctionOct 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT SOME RESISTANCE AND KINK OCCURRED A FEW TIMES WHEN OPENING AND CLOSING THE STONE BASKET, THE BASKET WAS DEFLECTED IN ANATOMY WHEN THIS OCCURRED. NOT ALL THE TIME, THE WHITE PROXIMAL PART WAS MOVING TOGETHER WITH THE RELEASE BUTTON. THE PROCEDURE WAS FINISHED WITHOUT ANY COMPLICATIONS, IT OCCURRED IN THE FINAL PART OF THE PROCEDURE, THE NURSE THAT HANDLED THE BASKET MEANT THAT IT WAS HER HANDLING BUT JUST TO MAKE SURE THAT THIS WAS NOT A NEW FINDING SO, THEY DID THIS COMPLAINT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 24SEP2024, CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384941 ↗
• MalfunctionJun 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE. PHYSICIAN STATED THEY WERE NOT ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE BECAUSE IMPACTED STONE THAT DID NOT COMPLETELY COME OUT IN RELATION TO 042400 ¿ SKYLITE TM 2.4 FR. NITINOL TIPLESS BASKET, 120CM X 12MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151372 ↗
• MalfunctionDec 12, 2019Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE USER DESCRIBED THE UNEXPECTED CHALLENGES FACED WITH THE STONE BASKET PRODUCT. THE USER SAID "BILE MOLD THAT INVOLVED ITS FRAGMENTATION TO OVERCOME IT AND EXTRACT IT."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9460035 ↗
• MalfunctionAug 14, 2019Break

  IT WAS REPORTED THAT THE SKYLITE BASKET HAD AN UNSPECIFIED MALFUNCTION. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON JUL 29 2019 THE HAND PIECE OF THE DEVICE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892379 ↗