Bard SkyLite Tipless Nitinol Stone BasketRecalls & reported problems across all models

We found 3 models of Bard SkyLite Tipless Nitinol Stone Basket by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between May 26, 2017 and Feb 23, 2026 — classified as 7 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard SkyLite Tipless Nitinol Stone Basket problems

Bard SkyLite Tipless Nitinol Stone Basket models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® SkyLite™ Tipless Nitinol Stone Basket 041900

  DISLODGER, STONE, BASKET, URETERAL, METAL
  78 reports
• Bard® SkyLite™ Tipless Nitinol Stone Basket 042400

  DISLODGER, STONE, BASKET, URETERAL, METAL
  7 reports
• Bard® SkyLite™ Tipless Nitinol Stone Basket 043000

  DISLODGER, STONE, BASKET, URETERAL, METAL
  2 reports

Recent Bard SkyLite Tipless Nitinol Stone Basket adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗

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