NephroMax Kit M0062101640Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729834533), received between Jan 29, 2020 and May 27, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AT 18 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400895 ↗
• MalfunctionJan 2, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 18 (ATM) ATMOSPHERIC PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427605 ↗
• MalfunctionFeb 4, 2020Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE ACCESS SHEATH BEING FRAGILE AND WEAK. "ADDITIONALY", IT WAS NOTICED THAT THE ACCESS SHEATH BREAKS AT THE TIP. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 Known Impact Or Consequence To Patient

  MAUDE report 9664291 ↗
• MalfunctionFeb 4, 2020Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE ACCESS SHEATH BEING FRAGILE AND WEAK. "ADDITIONALY", IT WAS NOTICED THAT THE ACCESS SHEATH BREAKS AT THE TIP. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 Known Impact Or Consequence To Patient

  MAUDE report 9664289 ↗
• MalfunctionFeb 4, 2020Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE ACCESS SHEATH BEING FRAGILE AND WEAK. "ADDITIONALY", IT WAS NOTICED THAT THE ACCESS SHEATH BREAKS AT THE TIP. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 Known Impact Or Consequence To Patient

  MAUDE report 9664288 ↗
• MalfunctionJan 29, 2020Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED DUE TO THE ACCESS SHEATH BEING FRAGILE AND WEAK. "ADDITIONALY", IT WAS NOTICED THAT THE ACCESS SHEATH BREAKS AT THE TIP. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641372 ↗