Zero Tip M0063901010Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729342007), received between Mar 15, 2018 and Nov 6, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Break; Device Damaged Prior to Use

  PRODUCT WAS REMOVED FROM PACKAGE AND BEFORE USE STONE BASKET WIRES WERE FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485382 ↗
• MalfunctionMay 27, 2025Difficult to Open or Close; Material Deformation; Material Split, Cut or Torn; Difficult to Open or Close; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. DURING THE PROCEDURE, THE PUSH HANDLE CANNOT BE OPENED NORMALLY. REPORTEDLY, THE NITINOL ALLOY WAS BENT, CAUSING DIFFICULTY IN OPENING AND CLOSING THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SHEATH TORN AT THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092847 ↗
• MalfunctionJan 17, 2024Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, BASKET WIRE AND THE HANDLE COMPLETELY DETACHED. THE PIECES WERE REMOVED UPON SEPARATION. 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 18528300 ↗
• InjuryJan 4, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THEY USED A ZERO TIP BASKET TO RETRIEVE A STONE; HOWEVER, A PIECE OF WIRE FROM THE DEVICE GOT DETACHED INSIDE THE PATIENT. IT WAS REPORTED THAT THEY USE ANOTHER BASKET TO RETRIEVE THE DETACHED PIECE AND 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 18449055 ↗
• MalfunctionMar 30, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS TO BE USED DURING A STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHILE UNPACKING, HOWEVER, THE PACKAGING OF THE ZERO TIP BASKET WAS DAMAGED AND WAS ALREADY OPEN. ANOTHER ZERO TIP BASKET WAS USED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642515 ↗
• MalfunctionMay 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE PACKAGE WAS OPENED AND FOUND THE WIRE IN THE BASKET WAS SEPARATED AND DISLODGED. ANOTHER ZERO TIP BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14355131 ↗
• MalfunctionNov 30, 2021Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED IN THE KIDNEY DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE BASKET WAS STUCK WITH A STONE INSIDE THE URETER. THE BASKET WIRE WAS LASERED TO RELEASE THE STONE AND REMOVED THE BASKET. THE PROCEDURE WAS COMPLETED WITH AN ESCAPE BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894654 ↗
• MalfunctionNov 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A ZERO TIP BASKET WAS USED TO REMOVE A GALLSTONE. HOWEVER, WHEN THE STONE WAS CAPTURED AND BEING REMOVED, A BASKET WIRE BROKE AND DETACHED INTO THE PATIENT. AS PER THE PHYSICIAN, THE DETACHED TIP WAS POSSIBLY "MILKED" OUT OF THE CYSTIC DUCT ALONG WITH THE GALLSTONE BUT WAS NOT VISUALIZED WITH THE NAKED EYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867854 ↗
• MalfunctionAug 31, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS UNPACKED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AT THE SIDE OF THE LABEL INSIDE THE PACKAGING WAS BLACK AND DIRTY, WHICH WAS CONFIRMED VIA A PHOTO SUBMITTED BY THE CUSTOMER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Patient Involvement

  MAUDE report 10472095 ↗
• InjuryJan 14, 2020Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP STONE RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A ZERO TIP BASKET WAS USED IN AN ATTEMPT TO REMOVE MULTIPLE STONES. HOWEVER, THE BASKET BECAME STUCK IN THE URETER WITH A STONE INSIDE, AND THE BASKET WAS UNABLE TO OPEN OR CLOSE. THE BASKET WAS CUT TO REMOVE THE FLEXIBLE URETEROSCOPE. A SEMI RIGID URETEROSCOPE WAS THEN USED WITH A LASER TO REMOVE THE BASKET. ONE OF THE BASKET WIRES WAS LEFT IN THE PATIENT AND WAS THEN EXTRACTED USING A DAKOTA BASKET. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587337 ↗
• MalfunctionNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP NITINOL BASKET WAS PREPPED FOR USE IN A FLEXIBLE URETEROSCOPY PROCEDURE TO TREAT KIDNEY STONE, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING AND TESTING OF THE DEVICE, IT WAS FOUND THAT THE BASKET CAGE WAS PHYSICALLY MISSING FROM THE DEVICE. THE SEAL OF THE PACKAGE WAS REPORTED TO BE INTACT BEFORE IT WAS OPENED AND THERE WERE NO NOTED DAMAGES ON THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WAS NO SERIOUS INJURY NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047118 ↗
• MalfunctionSep 13, 2018Difficult to Open or Close; Difficult to Open or Close

  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) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WOULD NOT OPEN TO RELEASE THE STONE. THE HANDLE WAS DISASSEMBLED IN ORDER TO OPEN THE BASKET AND RELEASE THE STONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WERE NO SERIOUS INJURIES NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872849 ↗
• InjuryAug 10, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP STONE RETRIEVAL BASKET WAS USED IN THE URETER FOR A LASER URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A ZERO TIP THE BASKET WAS USED IN AN ATTEMPT TO REMOVE A 4MM SIZED STONE. HOWEVER, THE STONE WAS TOO BIG TO BE REMOVED FROM THE URETER. THE WIRE OF THE BASKET WAS CUT TO RELEASE THE STONE BUT FAILED TO DO SO. A SEMI-RIGID SCOPE WAS THEN INSERTED INTO THE URETER AND THE USE OF FIBER WAS USED TO BREAK UP THE STONE, AND COMPLETE THE CASE. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S OUTCOME AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NO SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774313 ↗
• MalfunctionMar 22, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP¿ STONE RETRIEVAL BASKET WAS USED IN A FLEXIBLE URETERORENOSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT THERE WAS NO BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP¿ STONE RETRIEVAL BASKET. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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 Consequences Or Impact To Patient

  MAUDE report 7361292 ↗
• MalfunctionMar 15, 2018Break; 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) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE WIRE FROM THE HANDLE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7343331 ↗