Stone Cone M0063903200Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 08714729430223), received between Nov 18, 2016 and Mar 3, 2026 — classified as 16 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (41 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Peeled/Delaminated

  IT WAS REPORTED THAT A STONE CONE WAS USED DURING A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL HAD PEELED OFF AND COULD NOT BE USED. REPORTEDLY, THE ENTIRE BASKET DID NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE 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 24501045 ↗
• MalfunctionNov 10, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL WAS ABOUT TO BE USED ON A PROCEDURE. DURING UNPACKING, IT WAS OBSERVED THAT THE COIL WINDING WAS DIFFERENT FROM USUAL, AND THE WIRE OF BASKET WAS FOUND DAMAGED. ADDITIONALLY, THERE WAS A SEPARATION AND DETACHMENT OF THE BASKET PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511886 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL DEVICE WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTOMY PROCEDURE. REPORTEDLY, DURING PREPARATION IT WAS FOUND THAT THE DEVICE HAD NO STONE TAKING BASKET. IT WAS NOTED THAT THE COIL WAS DISCONNECTED WHEN OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385091 ↗
• MalfunctionApr 10, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL DEVICE WAS FOUND DAMAGED. REPORTEDLY, THE PACKAGING WAS NOT INTACT AND COMPROMISED RESULTING IN STERILITY ISSUE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21819403 ↗
• MalfunctionMar 26, 2025Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT A STONE CONE RETRIEVAL COIL WAS ABOUT TO BE USED DURING A URETEROSCOPIC LITHOTOMY PROCEDURE. REPORTEDLY, THE BASKET COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SHEATH AT COIL END WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698382 ↗
• MalfunctionNov 12, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A STONE CONE WAS GOING TO BE USED DURING A TRANSURETHRAL ELECTRONIC URETEROSCOPIC LITHOTRIPSY PROCEDURE. HOWEVER, AFTER UNPACKING, THE COIL WAS UNABLE TO RETRACT AND DEPLOY. THEREFORE, ANOTHER OF THE SAME DEVICES WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A SHEATH TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669082 ↗
• MalfunctionOct 31, 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 HOLMIUM LASER LITHOTRIPSY FOR URETERAL CALCULI PROCEDURE. IT WAS REPORTED THAT THE DEVICE COULD NOT BE DEPLOYED NORMALLY INSIDE THE PATIENT, AND IT WAS TAKEN OUT. HOWEVER, IT WAS FOUND THAT THE TIP OF THE BASKET WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577849 ↗
• MalfunctionAug 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNPACKING OF A NITINOL RETRIEVAL COIL DEVICE, IT WAS NOTED THAT THE FRONT OF THE DEVICE HAD NO HELIX STRUCTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096952 ↗
• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NITINOL RETRIEVAL COIL WAS ABOUT TO BE USED DURING A URETERAL CALCULI PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE END OF THE CLOSURE DEVICE WAS FRACTURED AND DETACHED. ADDITIONALLY, THE DEVICE COULD NOT BE CHANGED FROM THE BASKET BACK TO THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563803 ↗
• MalfunctionApr 12, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED DURING A LEFT TRANSURETHRAL URETEROSCOPE LASER LITHOTRIPSY PROCEDURE IN THE PYELOURETER PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS FOUND THAT THE COIL COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101358 ↗
• MalfunctionApr 9, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL COIL DEVICE WAS ABOUT TO BE USE DURING A URETERAL CALCULI PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE PART OF THE COIL TURNING TO A BASKET WAS KINKED AND FRACTURED. ADDITIONALLY, THE COATING PEELED OFF FROM THE INNER CORE WIRE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076577 ↗
• MalfunctionApr 9, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL COIL DEVICE WAS ABOUT TO BE USED DURING A URETERAL CALCULI PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, UPON OPENING THE PACKAGE THE SEALING AND COATING END OF THE BASKET WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074177 ↗
• MalfunctionMar 21, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NITINOL RETRIEVAL BASKET WAS USED DURING THE RIGHT TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STONE CONE WAS PLACED, A SMALL PORTION OF UNKNOWN LENGTH AS TORN OFF FROM THE STRAIGHT IMPERMEABLE MARKER AT THE TIP AND REMAINED IN THE URETER OR RETROPERITONEUM AFTER REPEATED MANIPULATION DUE TO URETERAL STRICTURE. THE BROKEN PIECE WAS UNABLE TO BE RETRIEVED; HOWEVER, A STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE PATIENT HAD AN INJURY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18950621 ↗
• MalfunctionNov 14, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL AT THE FRONT END OF THE DEVICE WAS DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL RETRIEVAL COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135480 ↗
• MalfunctionSep 5, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE COIL COULD NOT BE RETRACTED, AND THE TIP WAS FRACTURED. THE PROBLEM OCCURRED OUTSIDE THE PATIENT. ANOTHER STONE CONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686904 ↗
• MalfunctionAug 14, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED IN THE URETER DURING A TRANSURETHRAL URETEROSCOPY URETERAL PNEUMATIC BALLISTIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE STONE CONE DEVICE WAS UNPACKED AND WHEN MANIPULATED, THE BASKET WAS BROKEN UPON PULLING. ANOTHER STONE CONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON AUGUST 10, 2023. THE DISC SEALING PART AT THE TIP OF THE DEVICE WAS BROKEN. THE SURFACE OF THE COIL (GREEN/BLUE PTFE HEAT SHRINK) WAS COMPLETELY DAMAGED AND DETACHED, EXPOSING THE METAL STRUCTURE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545772 ↗
• MalfunctionJun 20, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS TO BE USED IN THE COMMON BILE DUCT DURING A URETEROLITHOTOMY PROCEDURE TO BE PERFORMED ON MAY 30, 2023. DURING THE PREPARATION, IT WAS OBSERVED THAT THE INNER PACKAGING OF THE DEVICE WAS NOT PROPERLY SEALED WHEN THE HOSPITAL STAFF OPENED THE OUTER PLASTIC PACKAGING FOR THE PROCEDURE. AS A RESULT, THE STERILITY REQUIREMENT COULD NOT BE MET. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163717 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SHEATH WAS DAMAGED OUTSIDE THE PATIENT. THERE WERE NO MORE STONE CONE AVAILABLE; THEREFORE, THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108236 ↗
• MalfunctionJun 1, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED IN THE URETER DURING A URETER LITHOTOMY PERFORMED ON (B)(6) 2023. DURING PREPARATION, A SLIT WAS FOUND IN THE INNER PACKAGING OF THE DEVICE, AND IT WAS NOT TIGHTLY PACKED. ANOTHER STONE CONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. 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 17037228 ↗
• MalfunctionMar 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A STONE CONE WAS TO BE USED ON A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE DEVICE PACKAGE WAS OPENED AND FOUND THE COIL OF THE STONE CONE WAS DEFORMED AND FLAT. THE PROCEDURE WAS ABORTED AND WAS POSTPONED ON AN UNKNOWN DATE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644878 ↗
• MalfunctionMar 21, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE BASKETS WAS USED ON A TRANSURETHRAL LITHOTOMY (TUL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, THE ATTACHED WIRE TORQUER WAS FOUND TO BE DAMAGED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE SHEATH BUCKED ACCORDION; THEREFORE, THIS IS NOW A NON MDR REPORTABLE EVENT (SEE BLOCK H10 FOR INVESTIGATION DETAILS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581934 ↗
• InjuryJan 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2022. THE COIL WAS DETACHED BASED ON THE PHOTO PROVIDED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235563 ↗
• MalfunctionDec 16, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE WAS USED IN DURING A STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2022. DURING WITHDRAWAL/CLOSURE, THE COIL BROKE IN TWO PARTS. THE PROCEDURE WAS COMPLETED WITH N-TRAP. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998919 ↗
• MalfunctionOct 21, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A URETERAL STONE CRUSHING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE COIL WAS FOUND CRACKED. ANOTHER STONE CONE 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 15649587 ↗
• MalfunctionAug 30, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL RETRIEVAL COIL WAS USED IN THE URETER DURING A LITHOTOMY UNDER URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS FOUND THAT THE BASKET WOULD OPEN TOO EASILY WITH A PULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE. 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. THE INVESTIGATION RESULTS REVEALED THE COIL/CONE PEELED/SHEARED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322867 ↗