NA M0064201110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729009733), received between May 1, 2019 and Feb 11, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEPHROSTOMY CATHETER SET WAS USED TO ESTABLISH PERCUTANEOUS NEPHROSTOMY ACCESS DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. FOLLOWING HOSPITAL DISCHARGE, THE PATIENT DEVELOPED A URINARY INFECTION DURING THE CATHETER INDWELLING PERIOD. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT RELATED TO THE DEVICE.

  Patient problems: Urinary Tract Infection

  MAUDE report 21352924 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEPHROSTOMY CATHETER SET WAS USED TO ESTABLISH PERCUTANEOUS NEPHROSTOMY ACCESS AND URINE DRAINAGE DURING A PERCUTANEOUS NEPHROSTOMY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2024. FOLLOWING HOSPITAL DISCHARGE, THE PATIENT EXPERIENCED BLEEDING DURING THE CATHETER INDWELLING PERIOD, REQUIRING INTERVENTION. ANGIOEMBOLIZATION WAS PERFORMED FOR RENAL BLEEDING, THOUGH DETAILS OF ANY ADDITIONAL INTERVENTION WERE NOT REPORTED. THE CATHETER WAS REMOVED ON (B)(6) 2024, WITH NO SERIOUS ADVERSE EVENTS REPORTED IN CONNECTION TO THIS INCIDENT. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT RELATED TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21343140 ↗
• MalfunctionJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NEPHROSTOMY CATHETER SET WAS USED TO ESTABLISH PERCUTANEOUS NEPHROSTOMY ACCESS AND URINE DRAINAGE DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT PULLED ON TUBE POST PROCEDURE AND DISLODGED IT FROM COLLECTING SYSTEM. THE CATHETER WAS REMOVED ON (B)(6) 2024. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260279 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEPHROSTOMY PERCUTANEOUS ACCESS SET WAS USED DURING A PERCUTANEOUS NEPHROSTOMY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. ON (B)(6) 2024, DURING HOSPITALIZATION AND PRIOR TO DISCHARGE THE PATIENT EXPERIENCED BLEEDING. REPORTEDLY, THERE WAS NO RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE NEPHROSTOMY PERCUTANEOUS ACCESS SET. ADDITIONALLY, THERE WAS NO REPORTED MALFUNCTION OR DEFICIENCY OF THE NEPHROSTOMY PERCUTANEOUS ACCESS SET. THE DEVICE WAS REMOVED ON (B)(6) 2024. NO INTERVENTION WAS REQUIRED FROM THE PATIENT OTHER THAN BEDREST. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21123958 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEPHROSTOMY PERCUTANEOUS ACCESS SET WAS USED DURING A PERCUTANEOUS NEPHROSTOMY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. ON (B)(6) 2024, DURING THE PROCEDURE THE PATIENT EXPERIENCED BLEEDING. REPORTEDLY, THERE WAS NO RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE NEPHROSTOMY PERCUTANEOUS ACCESS SET. ADDITIONALLY, THERE WAS NO REPORTED MALFUNCTION OR DEFICIENCY OF THE NEPHROSTOMY PERCUTANEOUS ACCESS SET. THE DEVICE WAS REMOVED ON (B)(6) 2024. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21123956 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUTANEOUS ACCESS SET WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED AS A MICROPUNCTURE SYSTEM; HOWEVER, THE INDICATION FOR USE OF THE DEVICE IS FOR PERCUTANEOUS NEPHROSTOMY. REPORTEDLY, THIS EVENT CAUSED DELAY TO THE PROCEDURE WHICH RESULTED TO PAIN AND BLEEDING OF THE PATIENT. THE REPORTED INJURY DOES NOT REQUIRE FURTHER MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUTANEOUS ACCESS SET. ADDITIONALLY, IT WAS CONFIRMED THAT THERE WAS NO ISSUE NOTED ON THE DEVICE. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 8570927 ↗