DAKOTA M0063905010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729937371), received between Jun 20, 2023 and Nov 28, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗