NephroMaxRecalls & reported problems across all models

We found 4 models of NephroMax by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2017 and Sep 16, 2026 — classified as 6 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NephroMax problems

NephroMax models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NephroMax M0062101170

  CATHETER, NEPHROSTOMY
  32 reports
• NephroMax M0062101400

  CATHETER, NEPHROSTOMY
  13 reports
• NephroMax M0062101420

  CATHETER, NEPHROSTOMY
  9 reports
• NephroMax M0062101440

  CATHETER, NEPHROSTOMY
  3 reports

Recent NephroMax adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 9, 2026Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED TO SET IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. REPORTEDLY, IT WAS NOTED THAT THE SHEATH CAME ON BACKWARDS UPON OPENING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773587 ↗
• MalfunctionApr 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A TINY HOLE IN THE BALLOON PART, SO IT DOES NOT EXPAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933158 ↗
• MalfunctionMar 30, 2026Burst Container or Vessel; Material Deformation

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE BLUE SHEATH HAD A DENT. ADDITIONALLY, THE BALLOON WOULD NOT INFLATE AT 18 ATMOSPHERE (ATM). REPORTEDLY, UPON PULLING OUT THE BALLOON TO REINFLATE IT POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715390 ↗
• MalfunctionMar 16, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE AND FOUND THAT IT HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613370 ↗
• 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 ↗
• MalfunctionSep 17, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, WHEN THEY WERE BLOWING UP THE BALLOON IT POPPED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077619 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS ABOUT TO BE USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL). DURING PREPARATION, IT WAS FOUND THAT THE BALLOON WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356535 ↗
• 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 ↗
• MalfunctionJul 1, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED BELOW 20 ATMOSPHERES (ATM); HOWEVER, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC FACIAL DILATOR WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652083 ↗
• MalfunctionMay 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NEPHROMAX BALLOON CATHETER AND PUMPED SALINE WITH AN ENCORE HIGH PRESSURE INFLATION AT 12 ATM; HOWEVER, THE BALLOON RUPTURED AND LEAKED INSIDE THE PATIENT. 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 19400886 ↗
• 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 ↗
• 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 ↗

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