DAKOTARecalls & reported problems across all models

We found 2 models of DAKOTA by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Nov 28, 2025 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (11 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 DAKOTA problems

DAKOTA models

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

• DAKOTA M0063905000

  DISLODGER, STONE, BASKET, URETERAL, METAL
  18 reports
• DAKOTA M0063905010

  DISLODGER, STONE, BASKET, URETERAL, METAL
  5 reports

Recent DAKOTA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 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 URETEROSCOPIC STONE EXTRACTION PROCEDURE. REPORTEDLY, THE BASKET WAS OPENING AND CLOSING AT FIRST BUT THEN IT STOPPED DEPLOYING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED BASKET IDENTIFIED THAT THE GRASPER WAS DETACHED FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671552 ↗
• 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 ↗
• InjuryJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DAKOTA RETRIEVAL BASKET WAS USED DURING A LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, AFTER USING A LASER FIBER, AND A DAKOTA BASKET TO REMOVE FRAGMENTS, THE BASKET BROKE. REPORTEDLY, THE DISTAL BASKET WAS REMOVED AND A CYSTOSCOPE ADVANCES PER URETHRA TO REMOVE THE BROKEN BASKET FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508427 ↗
• MalfunctionApr 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A DAKOTA RETRIEVAL BASKET WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. DURING THE PROCEDURE, THE BASKET DID NOT OPEN. ADDITIONALLY, THERE WAS A STONE INSIDE THE BASKET WHEN IT FAILED TO OPEN AND WAS REMOVED USING ANOTHER BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938444 ↗
• 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 ↗
• InjuryAug 30, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DAKOTA BASKET WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, SURGERY WAS PERFORMED AND FOUND A PART OF THE END EFFECTOR WIRE OF THE DAKOTA WAS COMPLETELY DETACHED AND HAS REMAINED INSIDE THE PATIENT. THE WIRE WAS RETRIEVED SURGICALLY. IT WAS UNKNOWN THAT THE WIRE OF THE BASKET DETACHED UNTIL THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650197 ↗
• InjuryJun 20, 2023Break; 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 THE DAKOTA BASKET WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2023. DURING A PROCEDURE, THE DAKOTA BASKET BROKE OFF INSIDE THE PATIENT NEAR THE RIGHT URETER. THE PHYSICIAN SUCCESSFULLY LOCATED AND REMOVED ALL THE BROKEN PIECES OF THE BASKET. NO ADDITIONAL FRAGMENTS WERE FOUND DURING THE PROCEDURE. THE COLLECTED BASKET FRAGMENTS WERE SECURELY PACKAGED IN A BAG FOR REPORTING AND FURTHER INVESTIGATION. THERE WERE NO PATIENT COMPLICATIONS 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 17165573 ↗
• 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 ↗

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