Stone ConeRecalls & reported problems across all models

We found 2 models of Stone Cone by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Mar 3, 2026 — classified as 24 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Stone Cone problems

Stone Cone models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Stone Cone M0063903200

  DISLODGER, STONE, FLEXIBLE
  87 reports
• Stone Cone M0063903100

  DISLODGER, STONE, FLEXIBLE
  21 reports

Recent Stone Cone adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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