Zero Tip M0063901050Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 08714729469643), received between Dec 20, 2016 and Sep 14, 2026 — classified as 110 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Break” (129 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that a Zero Tip Basket device was used during a Ureteroscopy Laser Lithography procedure. During the procedure, the end of the basket cage fell off. Reportedly, they grabbed another basket to retrieve the cage from the previous basket. The procedure was completed with another of the same device with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754793 ↗
• InjuryJul 8, 2026Break

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE, REPORTEDLY, WHEN THE BASKET WAS USED TO RETRIEVE THE STONE FRAGMENT, THE TIP BROKE INSIDE THE PATIENT. THE PHYSICIAN WAS USING THE BASKET WITH A LASER AND THERE WERE NO PIECES OF FRAGMENT WAS LEFT INSIDE THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25755185 ↗
• MalfunctionJul 8, 2026Detachment of Device or Device Component

  It was reported that during Ureterolithotomy procedure, a Zero Tip basket was used, and it was found that the whole basket fell off outside of the patient. The procedure was completed with another of the same device. No patient complications were report

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751066 ↗
• InjuryJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE BASKET BROKE INSIDE THE PATIENT WHILE PULLING OUT A KIDNEY STONE. THE BROKEN TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428727 ↗
• MalfunctionMay 15, 2026Break; Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT ZERO TIP BASKET DEVICE WAS USED DURING A TRANSURETHRAL RENOLITHOTRIPSY PROCEDURE. DURING PROCEDURE, THE WIRE GOT DAMAGE IN THE BASKET SECTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THE SHEATH WAS FOUND TO BE MELTED AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191484 ↗
• MalfunctionApr 14, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE A ZERO TIP WAS USED. IT WAS FOUND THAT THE WIRE WAS DAMAGED AND WAS SEPARATED AND DETACHED FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872666 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE A ZERO TIP NITINOL STONE RETRIEVAL WAS USED. THE BASKET BROKE OFF INSIDE THE URETER DURING ATTEMPT TO REMOVE THE BROKEN NEPHROSTOMY TUBE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24866763 ↗
• MalfunctionApr 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO ZERO TIP BASKET DEVICES WERE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET PORTION BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND ZERO TIP BASKET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO ZERO TIP BASKET DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767737 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO ZERO TIP BASKET DEVICES WERE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE BASKET PORTION BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND ZERO TIP BASKET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO ZERO TIP BASKET DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753973 ↗
• MalfunctionMar 11, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A ZERO TIP WAS USED DURING A URETEROSCOPY LASER LITHOTRIPSY PROCEDURE. PRIOR TO PROCEDURE, A BLACK SPECS WERE FOUND FLOATING IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568785 ↗
• InjuryMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP WAS USED DURING PROCEDURE. IT WAS FOUND THAT THE BASKET BROKE INSIDE THE PATIENT RESULTING IN ADDITIONAL SURGERY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562941 ↗
• InjuryMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, TONE RETRIEVAL BASKET WAS ADVANCED THROUGH A SEMIRIGID URETEROSCOPE AND DEPLOYED TO CAPTURE THE STONE; HOWEVER, A RESISTANCE WAS ENCOUNTERED DURING ATTEMPTED WITHDRAWAL OF THE BASKET WITH THE CAPTURED STONE, AND THE BASKET BROKE IN THIS ATTEMPT. REPORTEDLY, THE URETEROSCOPE WAS WITHDRAWN AND A 16 FR FOLEY CATHETER WAS PLACED FOR URINARY DRAINAGE, AND A GUIDEWIRE WAS LEFT IN PLACE VIA THE CATHETER. A CLEAR URINE DRAINAGE WAS OBSERVED AT THE CONCLUSION OF THE CASE WITH NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562929 ↗
• MalfunctionMar 10, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROLITHOTOMY (TUL) PROCEDURE. POST PROCEDURE, THE FRONT FOUR CLAWS AND THE ENTIRE BASKET DETACHED. REPORTEDLY, THE DETACHED BASKET DID FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562905 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET WAS USED DURING A URETEROLITHOTOMY PROCEDURE. DURING THE PROCEDURE CLOSURE, IT WAS FOUND THAT THE WHOLE BASKET FELL OFF BUT IT DID NOT FALL INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501036 ↗
• MalfunctionFeb 27, 2026Nonstandard Device; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROLITHOTOMY PROCEDURE. REPORTEDLY, POST PROCEDURE IT WAS FOUND THAT THE FRONT FOUR CLAWS AND THE COATING OF THE BASKET WAS DETACHED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468870 ↗
• MalfunctionFeb 18, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A URETEROLITHOTOMY PROCEDURE A ZERO TIP BASKET WAS INTENDED TO BE USED, IT WAS FOUND THAT FRONT FOUR CLAWS WERE DETACHED, HOWEVER, IT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379308 ↗
• MalfunctionFeb 6, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PLASTIC AROUND THE ZERO TIP BASKET DEVICE HAD A HOLE IN IT, DOWN TOWARDS THE BOTTOM, MAKING IT NON-STERILE. THERE WERE NO PATIENT AND PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283313 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE WIRE WAS DAMAGED AND SEPARATED FROM THE BASKET SECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264158 ↗
• InjuryJan 26, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, THE ENTIRE BASKET BREAK AND DETACHED. REPORTEDLY, IT WAS RETRIEVED USING ANOTHER BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184914 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS SET TO BE USED DURING A KIDNEY STONE REMOVAL PROCEDURE. REPORTEDLY, AFTER UNPACKING IT WAS FOUND THAT ONE OF THE BASKET WIRES COMPLETELY FELL OFF FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088620 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT, AT THE END OF THE PROCEDURE, IT WAS OBSERVED THAT THE "FRONT FOUR [BASKET WIRES]" WERE DETACHED BUT HAD NOT FALLEN INTO THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935941 ↗
• MalfunctionDec 26, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USE DURING A PROCEDURE. REPORTEDLY, ONE OF THE BASKET WIRES BROKE; HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT ONE OF THE BASKET WIRES BREAK AND FULLY DETACHED FROM THE BASKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897640 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE FOR STONE REMOVAL. DURING THE PROCEDURE, A PIECE OF BASKET BROKE OFF WHILE IN PATIENT. REPORTEDLY, THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716777 ↗
• MalfunctionNov 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS SET TO BE USE DURING A PROCEDURE. DURING UNPACKING, A HOLE WAS FOUND IN THE STERILE PACKAGING. THERE WERE NO PROCEDURE AND PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671867 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS SET TO BE USED DURING A URETERAL CALCULI PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT ONE END OF THE BASKET WAS FRACTURED. IT WAS FURTHER CLARIFIED THAT THE ENTIRE BASKET WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617023 ↗