DAKOTA M0063905000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729937364), received between Jun 22, 2018 and Nov 24, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT A DAKOTA RETRIEVAL BASKET WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. REPORTEDLY, THE DEVICE WOULD NOT OPEN OR CLOSE AFTER MULTIPLE TRIES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED BASKET IDENTIFIED THAT THE GRASPER RETURNS DETACHED FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638969 ↗
• MalfunctionNov 14, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT A DAKOTA RETRIEVAL BASKET WAS USED DURING A CYSTO LITHO LASER PROCEDURE. DURING THE PROCEDURE, THE BASKET DID NOT OPEN COMPLETELY. THE PROCEDURE WAS COMPLETELY WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT ONE OF THE LONG LEG GRASPER WIRES WAS BROKEN AND FULLY DETACHED FROM THE ASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555177 ↗
• InjuryApr 21, 2025Break; Break

  IT WAS REPORTED THAT A DAKOTA RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. REPORTEDLY, 10 INCHES OF THE DEVICE SNAPPED OFF AND REMAINED INSIDE THE PATIENT'S LEFT URETER. THE BROKEN PORTION WAS SUCCESSFULLY REMOVED USING ANOTHER GRASPING DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877431 ↗
• InjuryNov 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 THAT A DAKOTA BASKET WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, THE BASKET BROKE OFF AND THE END EFFECTOR WIRE DETACH COMPLETELY FROM THE GRASPER INSIDE THE PATIENT. THE WIRE HAD TO BE RETRIEVED WITH A SECOND BASKET AND NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729011 ↗
• MalfunctionJan 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA RETRIEVAL BASKET WAS ABOUT TO BE USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS FOUND THAT THE BASKET WIRE WAS BROKEN AND DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA RETRIEVAL BASKET DEVICE. 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 18587059 ↗
• MalfunctionJan 3, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA RETRIEVAL BASKET WAS ABOUT TO BE USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA RETRIEVAL BASKET DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437773 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA RETRIEVAL BASKET WAS TO BE USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2023. PRIOR TO THE PROCEDURE, THE TIP OF THE DAKOTA BASKET WIRE WAS BROKEN AND DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA RETRIEVAL BASKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259696 ↗
• MalfunctionMay 15, 2023Difficult to Open or Close

  DURING A CYSTOSCOPY LASER STENT PROCEDURE IN OPERATING ROOM A DAKOTA BASKET WAS ATTEMPTED TO BE USED. WHILE CHECKING THE DEVICE FOR FUNCTIONALITY, THE DEVICE WOULD NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929783 ↗
• InjuryJul 18, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE RIGHT KIDNEY DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE BASKET FAILED TO OPEN COMPLETELY. ANOTHER BASKET WAS USED TO REMOVED THE STONE STUCK INSIDE THE DEFECTIVE BASKET AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041426 ↗
• MalfunctionApr 14, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA WAS TO BE USED IN A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS FOUND THAT THE TAPE USED TO SEAL THE SHIPPING BOX WAS ALSO TAPED ON THE STERILE PACKAGING WHICH LEAD TO THE STERILE PACKAGING BEING DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110954 ↗
• MalfunctionFeb 8, 2022Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE URETHRA DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A DAKOTA BASKET WAS USED TO REMOVE STONES. THE BASKET OPENED AND CLOSED ON THE FIRST AND SECOND TIME. HOWEVER, IT FAILED TO OPEN ON THE THIRD TIME. THE PHYSICIAN ATTEMPTED TO OPEN SEVERAL TIMES BUT THE HANDLE BROKE. THE STONE IN THE KIDNEY COULD NOT BE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS RESCHEDULED ON (B)(6) 2022. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483283 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE URETER DURING A UROLITHIASIS CRUSHING PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, AFTER A FEW TIMES GRIPPING THE STONE, THE BASKET WIRE BROKE. THE BASKET WIRES WERE STILL ATTACHED AT THE OTHER END. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548108 ↗
• MalfunctionSep 14, 2021Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON(B)(6), 2021. DURING PREPARATION, THE BASKET FAILED TO OPEN WHEN THE PHYSICIAN TRIED TO OPEN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT (SEE BLOCK H10 FOR INVESTIGATION DETAILS). ***ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021*** THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA BASKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468097 ↗
• MalfunctionJun 28, 2021Difficult 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 TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DAKOTA BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE SHEATH WAS TORN AT THE DISTAL END; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077458 ↗
• MalfunctionAug 7, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET DEVICE WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A SLIT WAS NOTICED ON THE PACKAGING. ANOTHER DAKOTA BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10379644 ↗
• InjuryApr 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA RETRIEVAL BASKET WAS USED IN THE LUMBAR URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PIECE OF THE BASKET'S END EFFECTOR BROKE AND DETACHED INTO THE PATIENT'S URETER. ANOTHER DAKOTA WAS USED TO RETRIEVE THE DETACHED PIECE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911582 ↗
• MalfunctionFeb 7, 2020Difficult to Open or Close

  THE DEVICE WOULD NOT OPEN PER SURGEON. A NEW DAKOTA WAS OPENED AND WORKED PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9681192 ↗
• InjuryJun 22, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE WAS USED IN THE URETER AND KIDNEY DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN A STONE WAS CAPTURED IN THE DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE WITH OPENSURE¿ HANDLE, THE PHYSICIAN ATTEMPTED TO REMOVE THE STONE THROUGH THE ACCESS SHEATH. HOWEVER, THE STONE WAS TOO LARGE TO BE REMOVED. AN ATTEMPT TO RELEASE THE STONE WAS DONE BY TRYING TO PUSH THE DAKOTA¿ WITH ENTRAPPED STONE BACK INTO THE KIDNEY, BUT AGAIN THE STONE WAS UNABLE TO BE RELEASED. THE END EFFECTOR WIRE OF THE DAKOTA¿ BROKE. THE PHYSICIAN THEN PULLED THE DAKOTA¿ WITH ENTRAPPED STONE BACK TO THE ACCESS SHEATH, AND REMOVED THEM ALL TOGETHER FROM THE PATIENT. DURING THE REMOVAL, HOWEVER, THE URETER WAS PERFORATED AND WAS BLEEDING. A CAUTERY DEVICE FROM ANOTHER MANUFACTURER WAS USED TO TRY TO STOP THE BLEEDING, BUT IS UNKNOWN IF THERE WAS ANY TREATMENT GIVEN FOR THE PERFORATION. 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: Internal Organ Perforation

  MAUDE report 7628646 ↗