Zero Tip M0063901040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729469636), received between Feb 14, 2022 and Dec 29, 2025 — classified as 3 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USE DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, THEY FOUND THAT THE BASKET WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT TWO BASKET WIRES BROKE AND FULLY DETACHED FROM THE BASKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905884 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET, FLEXIVA PULSE LASER FIBERS, AND A DUAL LUMEN URETERAL CATHETER WERE USED IN THE LEFT KIDNEY DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED PYELITIS AND CYSTITIS. THE PATIENT TOOK PERCOCET 5-325MG FOR THE PYELITIS UNTIL (B)(6) 2022. FOR CYSTITIS, THE PATIENT TOOK CEPHALEXIN 500MG AND WAS STOPPED ON (B)(6) 2022.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15199387 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE ID LASER FIBER AND A ZERO TIP BASKET WERE USED DURING A LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE BLADDER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS PULSE 100 H LASER CONSOLE WITH LASER SETTINGS OF 0.6 JOULES, 6 HERTZ AND 4 WATTS. ON (B)(6) 2022, FIVE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED CYSTITIS. SHE WAS TREATED WITH CEPHALEXIN ORAL FOR INFECTION AND PROCHLORPERAZINE IV FOR NAUSEA AND THE PATIENT'S CONDITION WAS RESOLVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 15125302 ↗
• InjuryFeb 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A LASER WAS USED ON THE LEFT URETERAL STONE. THE ZERO TIP BASKET WAS THEN USED TO RETRIEVED THE STONES. HOWEVER, THE BASKET WIRES BROKE INTO TWO SEPARATE PIECES WITHIN THE URETER. A DIFFERENT TYPE OF BASKET WAS USED TO SNARE THE BROKEN PIECES. THE PROCEDURE WAS DELAYED APPROXIMATELY 15 - 20 MINUTES DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525206 ↗