NephroMax M0062101420Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729826491), received between Jun 1, 2017 and Nov 28, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE WITH SHOCK PULSE. DURING THE PROCEDURE, UPON INSERTING THE NEPHROMAX BALLOON CATHETER, THEY NOTICED THAT THE SMALL GOLD RADIO OPAQUE STRIP AT THE DISTAL END OF THE WORKING SHEATH FELL OFF INSIDE THE PATIENT. THEY ATTEMPTED RETRIEVAL FOR APPROXIMATELY 30 MINUTES SINCE IT KEPT MOVING THE DISLODGED TAB INTO UNREACHABLE AREAS. REPORTEDLY, ANOTHER SURGEON WAS ABLE TO VISUALIZE THE GOLD TAB AND COMPLETELY REMOVE IT FROM THE PATIENT USING A TWO AND THREE PRONG GRASPER FROM PERCUTANEOUS SET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO SERIOUS HARM DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671993 ↗
• InjuryMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE RADIOPAQUE MARKER ON THE CLEAR RENAL SHEATH CAME OFF OF THE SHEATH AFTER IT WAS INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509977 ↗
• MalfunctionApr 26, 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 INFLATED RIGHT UNDER 20 ATMOSPHERES; HOWEVER, THE BALLON 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 19195556 ↗
• MalfunctionMay 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. PRIOR TO THE PROCEDURE, A DISCOLORATION ON THE DEVICE WAS NOTED. A PHOTO SUBMITTED BY THE CUSTOMER SHOWED THE DISCOLORATION ON THE CATHETER NEAR THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862312 ↗
• MalfunctionMay 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING UNPACKING, WHAT SEEMS TO BE A BURN MARK WAS NOTED ON THE CATHETER NEAR THE BALLOON. A PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THE FOREIGN MATERIAL PRESENT ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769283 ↗
• MalfunctionFeb 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THERE WERE BROWN DEBRIS ON THE BALLOON. 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 9720168 ↗
• MalfunctionFeb 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THERE WERE BROWN DEBRIS ON THE BALLOON. 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 9719964 ↗
• MalfunctionAug 22, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WAS UNABLE TO BE INFLATED. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 8920238 ↗
• MalfunctionJun 1, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, WHEN THEY OPENED THE OUTER BOX, THE STERILE PACKAGING OF THE DEVICE WAS ALREADY OPENED. THERE WAS NO VISIBLE DAMAGE NOTED ON THE OUTER BOX. REPORTEDLY, THIS DEVICE WAS NOT USED IN A PATIENT OR PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6604044 ↗