Zero Tip M0063901020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729342014), received between Sep 14, 2018 and Mar 2, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Separation

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE OUTER SHEATH FROM THE BASKET DURING THE CASE AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490076 ↗
• MalfunctionJul 2, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED IN A URETERORENOSCOPY AND LITHOTRIPSY PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE OUTER CASING NET OF THE DEVICE HAS BURRS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382507 ↗
• MalfunctionJan 13, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, WHEN USING THE BASKET, THE WIRE SUDDENLY BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144771 ↗
• MalfunctionDec 1, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS ABOUT TO BE USED DURING A URETERORENOSCOPY (URS) PROCEDURE PERFORMED ON (B)(6), 2023. PRIOR TO THE PROCEDURE, UPON CHECKING THE BASKET IT WAS FOUND THAT THE TIP WAS BROKEN AND COMPLETELY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250151 ↗
• MalfunctionAug 16, 2019Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP RETRIEVAL BASKET WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS UNABLE TO OPEN AND CLOSE. THE PROCEDURE COMPLETED WITH THE ANOTHER ZERO TIP BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE SHEATH TORN AT DISTAL END AND BASKET DETACHED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903146 ↗
• InjurySep 14, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS OPENED FOR USE FOR A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WIRE BROKE OFF INSIDE THE PATIENT WHILE ATTEMPTING TO REMOVE A STONE. THE BROKEN WIRE WAS RETRIEVED WITHOUT A PROBLEM. ALL PIECES WERE RETRIEVED AND REMOVED INTACT FROM THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878582 ↗