Zero Tip M0063901030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729342021), received between Feb 11, 2020 and Aug 27, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A RIGHT URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PATIENT UNDERWENT REMOVAL OF THE URETERAL STONES; HOWEVER, SUBSEQUENTLY A CT SCAN REVEALED A 12CM LINEAR METALLIC WIRE IN THE RIGHT URETER OF THE PATIENT. REPORTEDLY, THE RETAINED BASKET WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906892 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS). DURING THE PROCEDURE, AFTER REMOVING A FEW STONES AND WHILE THE BASKET WAS OUT OF THE PATIENT IT WAS NOTICED THAT THE PULL WIRE WAS PARTIALLY DETACHED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381510 ↗
• MalfunctionOct 3, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE USING A ZERO TIP BASKET, THE OUTER SHEATH OF THE BASKET THAT ATTACHED TO THE HANDLE SLID OFF AND THE BASKET STOPPED WORKING. THE PULLWIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359645 ↗
• MalfunctionSep 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZERO TIP BASKET WAS USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE ZERO TIP BASKET WAS INSERTED INTO THE URETEROSCOPE WORKING CHANNEL AND A THREAD WAS FOUND AT THE TIP OF THE SHEATH. PHOTOS PROVIDED BY THE CUSTOMER CONFIRMED THE TIP OF THE SHEATH WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518909 ↗
• MalfunctionFeb 11, 2020Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP RETRIEVAL BASKET WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE SHEATH IS TORN AT DISTAL END; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695141 ↗