NephroMax M0062101400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729826484), received between Jun 27, 2019 and Sep 16, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787485 ↗
• MalfunctionMar 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600580 ↗
• MalfunctionAug 22, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS PLACED OVER THE CATHETER AND ADVANCE TO THE COLLECTING SYSTEM; HOWEVER, UPON INFLATING THEY NOTICED A LEAKING AND FOUND OUT THAT THE BALLOON BURST AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041027 ↗
• MalfunctionMar 4, 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 NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN INFLATED THE BALLOON AND IT BURST. 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 18828023 ↗
• MalfunctionNov 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON POP WHEN RISING THE PRESSURE TO 12 ATM (ATMOSPHERE). THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097849 ↗
• MalfunctionApr 29, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A NEPHROMAX DILATATION BALLOON CATHETER DEVICE WAS USED IN THE RIGHT KIDNEY, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. PERFORMED ON (B)(6) 2020. IT WAS REPORTED, THAT DURING PREPARATION, THE BALLOON EXPLODED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021. IT WAS REPORTED, THAT THE BALLOON EXPLODED IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748215 ↗
• MalfunctionSep 28, 2020Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO THREE NEPHROMAX DILATATION BALLOON CATHETERS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE RIGHT KIDNEY DURING A RIGHT PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596748 ↗
• MalfunctionSep 28, 2020Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO THREE NEPHROMAX DILATATION BALLOON CATHETERS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE RIGHT KIDNEY DURING A RIGHT PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596746 ↗
• MalfunctionSep 28, 2020Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO THREE NEPHROMAX DILATATION BALLOON CATHETERS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE RIGHT KIDNEY DURING A RIGHT PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596743 ↗
• MalfunctionJul 24, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON LEAKED FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER. 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. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319636 ↗
• MalfunctionAug 6, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON DILATATION CATHETER DEVICE WAS USED IN THE LEFT KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND BURST WITHIN RATED PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON DILATATION CATHETER 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864080 ↗
• MalfunctionJun 27, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO NEPHROMAX BALLOON DILATATION CATHETER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON DILATATION CATHETER DEVICES WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INSERTED OVER THE WIRE AND WAS INFLATED, HOWEVER; IT DID NOT REACH 20ATM AND BURST. THE SAME ISSUE OCCURED ON THE SECOND NEPHROMAX BALLOON DILATATION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739280 ↗
• MalfunctionJun 27, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO NEPHROMAX BALLOON DILATATION CATHETER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON DILATATION CATHETER DEVICES WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INSERTED OVER THE WIRE AND WAS INFLATED, HOWEVER; IT DID NOT REACH 20ATM AND BURST. THE SAME ISSUE OCCURED ON THE SECOND NEPHROMAX BALLOON DILATATION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738902 ↗