Stone Cone M0063903100Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729430209), received between Nov 23, 2016 and Jan 28, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A STONE CONE COIL RETRIEVAL WAS USED DURING THE PROCEDURE. REPORTEDLY, THE RETRIEVAL COIL DISTAL TIP FRACTURED WHILE STILL IN SITU. THE TIP WAS SUCCESSFULLY RETRIEVED, AND NO COMPONENTS WERE LEFT IN SITU. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203052 ↗
• MalfunctionOct 30, 2024Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NITINOL RETRIEVAL COIL DEVICE WAS USED DURING A URETEROLITOTOMIA PROCEDURE. DURING THE PROCEDURE, THE DEVICE GOT FRACTURED AT THE DISTAL END. ADDITIONALLY, THE DEVICE END WAS STUCK, AND IT WAS NOT FUNCTIONAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574840 ↗
• MalfunctionApr 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL COIL DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS FOUND THAT THE SHEATH WAS TORN UPON OPENING THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052987 ↗
• InjuryMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL COIL WAS USED IN URETERAL STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE STONE CONE FELL OFF. IT IS UNKNOWN IF THIS WAS CAUSED BY THE HIT OF THE LASER. THE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857443 ↗
• InjuryFeb 19, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STONE CONE WAS USED TO AVOID MIGRATION OF THE STONES; HOWEVER, IT WAS NOTICED THAT ONE PORTION OF THE CONE WAS STILL INSIDE THE PATIENT. IT WAS REPORTED THAT THE PIECE WAS REMOVED INSIDE THE PATIENT USING A DAKOTA BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER NITINOL RETRIEVAL BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735478 ↗
• MalfunctionFeb 6, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE SHEATH ON THE DISTAL TIP OF THE COIL PEELED BASED ON THE PHOTO PROVIDED BY THE CUSTOMER. 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 16302751 ↗
• MalfunctionApr 27, 2022Peeled/Delaminated; Difficult to Open or Close; Peeled/Delaminated; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE FAILED TO CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THE COIL/CONE PEELED/SHEARED AND THE TIP SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220346 ↗
• MalfunctionJan 7, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE DISTAL TIP OF THE SHEATH WAS DAMAGED DURING LASER RADIATION. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196602 ↗
• InjuryOct 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STONE CONE WAS INSERTED INTO THE URETER AND WAS OPENED BEHIND A STONE. HOWEVER, WHEN CLOSED AND PULLED BACK, THE TIP WAS FOUND TO BE DETACHED INTO THE UTERUS. THE DETACHED TIP WAS RETRIEVED WITH A FORCEPS. LITHOTRIPSY WAS PERFORMED WITH A NON-BSC THULIUM LASER DEVICE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10695591 ↗
• MalfunctionAug 27, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH ON THE DISTAL TIP OF THE COIL DETACHED INTO THE PATIENT. THE DETACHED PART HAD FLUSHED OUT NATURALLY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460360 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE MEDIAL URETER DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONE CONE WAS INSERTED INTO THE URETER. HOWEVER, THE DEVICE WAS UNABLE TO FORM A COIL AND BECAME DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE 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 STABLE. INVESTIGATION RESULTS REVEALED THE COIL WAS DETACHED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10249884 ↗
• InjuryOct 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY AND STENTING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COIL DETACHED AND FELL INTO THE PATIENT. A ZERO TIP BASKET WAS USED TO REMOVE THE COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE PROCEDURE WAS COMPLETED WITH THE ZERO TIP BASKET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246474 ↗
• MalfunctionAug 7, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN A TRANSURETHRAL LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO OPEN AND CLOSE ON THE FIRST ATTEMPT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE COIL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE COIL WAS PEELED/SHEARED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871384 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL THAT WAS USED DURING A PROCEDURE. IT WAS FOUND THAT THE CONE WAS BROKEN, AND THERE WAS SLIGHT DISCOLORATION AROUND THE BREAK. 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 8871112 ↗
• MalfunctionMay 20, 2019Peeled/Delaminated; Material Deformation; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS TO BE USED IN A PROCEDURE TO BE PERFORMED IN THE URETERAL CANAL ON (B)(6) 2019. THE BASKET WAS TO BE USED AFTER STONE CRUSHING WAS PERFORMED. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE COIL WAS FOUND CRUSHED AND THE SHAPE WAS FOUND TO BE STRAIGHT WHEN REMOVED FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE:THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; COIL/CONE PEELED/SHEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626187 ↗
• MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED IN A RIGID URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONE CONE FAILED TO STRAIGHTEN AFTER IT COILED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION FINDINGS COIL/COATING PEELED/SHARED/FRAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906508 ↗
• InjuryMar 29, 2018Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN THE KIDNEY DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 270 MICRON LASER FIBER WAS USED TO FRAGMENT A STONE POSITIONED UNDER THE COIL. HOWEVER, THE DISTAL PORTION OF THE COIL BROKE OFF AND MIGRATED TO THE LOWER CALYX OF THE LEFT KIDNEY MAKING VISUALIZATION OF THE BROKEN PORTION DIFFICULT. THE BROKEN PORTION OF THE CONE EVENTUALLY MIGRATED TO THE LEFT ILIOLUMBAR URETER AND ANOTHER URETHROSCOPY FOR EXTRACTION WAS PERFORMED. A MONTH AFTER THE PROCEDURE, DURING FOLLOW-UP VISIT, A KIDNEY SCAN WAS PERFORMED AND A FOREIGN BODY WAS FOUND IN THE KIDNEY. ON (B)(6) 2018, A PROCEDURE WAS PERFORMED TO REMOVE THE PIECE OF THE STONE CONE FROM THE PATIENT¿S KIDNEY. 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 ¿NO PROBLEM¿. 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

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7381660 ↗
• InjuryJul 21, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN THE URETER ON A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONE CONE RETRIEVAL DEVICE FAILED TO RETRACT INTO THE SHEATH. THE RETRIEVAL DEVICE WAS REMOVED TOGETHER WITH THE SCOPE FROM THE PATIENT'S BODY. HOWEVER, WHEN THE DEVICE WAS REMOVED IT WAS FOUND THE TIP BROKE AND DETACHED. A GRASPING FORCEPS WAS USED TO RETRIEVED THE DETACHED TIP. FLUOROSCOPY CONFIRMED THAT NO DEVICE FRAGMENTS ARE LEFT INSIDE THE PATIENT. ADDITIONALLY, IT WAS REPORTED THAT A LASER WAS USED DURING THE PROCEDURE BUT IT DID NOT DAMAGE THE RETRIEVAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731037 ↗
• MalfunctionJun 16, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROLITHOTOMY PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE END OF THE BLUE SHEATH ACCORDIONED WHEN ATTEMPTING TO CLOSE THE DEVICE. THE COIL FAILED TO CLOSE AND THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE URETER. DEVICE WAS DISASSEMBLED AND WAS REMOVED FROM THE PATIENT. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; CORE WIRE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6649024 ↗
• MalfunctionFeb 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS POSITIONED IN THE URETER, HOWEVER, THE DEVICE FAILED TO OPEN. THE DEVICE WAS THEN REMOVED FROM THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL UROLOGICAL RETRIEVAL. 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 STABLE. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE COIL/CONE DETACHED OR SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6293416 ↗
• InjuryNov 23, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. THE DETACHED PART WAS SUCCESSFULLY RETRIEVED USING ENDOSCOPIC FORCEPS. 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 WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6123604 ↗