NephroMax Kit M0062101600Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729834540), received between Jun 8, 2017 and Apr 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

   Z-2535-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO ACCESS TO THE TRACK; HOWEVER, 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 24769102 ↗
• MalfunctionOct 16, 2025Break; Fluid/Blood Leak; Material Split, Cut or Torn; Break; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, AFTER THE PATIENT UNDERWENT RIGHT PERCUTANEOUS NEPHROLITHOTOMY (PCNL) THE NEPHROSTOMY TUBE FELL APART WHERE THE TUBING MEETS THE LUER LOCK HUB. REPORTEDLY, IT WAS FOUND THAT THE TUBE NEAR THE HUB WAS BROKEN AND IT WAS NOTICING A LEAKAGE FROM THE TUBE. THIS REQUIRES REPLACING THE TUBE AND THE PATIENT FELT DISCOMFORT AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 23318485 ↗
• MalfunctionJul 7, 2025Burst 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 BURST WHILE INFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22422691 ↗
• MalfunctionSep 18, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED INT HE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AS IT WAS BEING INFLATED. 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 17765745 ↗
• MalfunctionSep 18, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED INT HE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE BALLOON BURST BEFORE IT WAS FULLY INFLATED. 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 17765547 ↗
• MalfunctionMar 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  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) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS A NARROW SPOT IN THE BALLOON AND THE RENAL SHEATH DID NOT CROSS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON TORN LONGITUDINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652909 ↗
• MalfunctionOct 14, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED TO 17 ATM, THE PHYSICIAN PROCEEDED TO INSERT THE SHEATH INTO THE INCISION; HOWEVER, THE BALLOON SUDDENLY BURST EVEN BEFORE THE SHEATH COULD BE FULLY INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER KIT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631329 ↗
• MalfunctionNov 9, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON DILATATION CATHETER DEVICE WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PINHOLE WAS NOTED. REPORTEDLY, THE BALLOON WAS CHECKED OUTSIDE THE PATIENT AND CONFIRMED THAT THE PINHOLE WAS IN THE MIDDLE PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10808911 ↗
• MalfunctionJul 25, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED DURING A PERCUTANEOUS URINARY TRACT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED AT 18 ATMOSPHERIC PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON KIT . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7717735 ↗
• MalfunctionNov 30, 2017Material Rupture; Material Rupture

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE DEFLATION, THE BALLOON RUPTURED. THERE WERE NO PIECES OF THE BALLOON THAT DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. REGARDING THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE, IT WAS NOTED THAT THERE WERE NO ADVERSE EVENTS OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070411 ↗
• MalfunctionJun 8, 2017Material Rupture; Material Rupture

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PREFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN IT WAS INFLATED AT 14 OR 15 ATM. NO PIECES WERE DETACHED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX 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 AS "NO PATIENT CONSEQUENCES".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6623290 ↗