NephroMax Kit M0062101620Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729834526), received between Jun 4, 2019 and Aug 26, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BENT AND SQUASHED WHICH COULD CAUSE DAMAGE TO THE KIDNEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893312 ↗
• MalfunctionJan 8, 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 PHYSICIAN WAS TRYING TO INFLATE THE BALLOON AND NOTICED UNDER FLOURO THAT THE BALLOON WAS NOT TAKING SHAPE. REPORTEDLY, UPON DEFLATING AND PULLING OUT THE BALLOON IT BURST, AND THE PRESSURE WAS AT 20 ATMOSPHERES (ATM). THEY TRIED RE-INFLATING THE BALLOON, BUT IT WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107952 ↗
• MalfunctionDec 20, 2022Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON DECEMBER 1, 2022. DURING THE PROCEDURE, THE RENAL SHEATH WAS ADVANCED AND IT WAS NOTICED THAT THE RADIOPAQUE MARKER WAS DAMAGED AND BENT. UNDER EXAMINATION, THE RADIOPAQUE MARKER FELL OFF THE SHEATH AND WAS REMOVED. REPORTEDLY, SOME BLEEDING OCCURRED DURING DEFLATION OF THE BALLOON; HOWEVER, THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 19, 2022 THAT THE BALLOON WAS NOT RUPTURED AND DAMAGED. THE BLEEDING WAS CONTROLLED BY THE PHYSICIAN'S EXPERTISE AND THE PATIENT WAS DOING WELL. REPORTEDLY, THE PHYSICIAN COULD NOT USE FLURO WHEN ADVANCING SO ADVANCEMENT OF THE SHEATH WAS DONE UNDER DIRECT VISUALIZATION. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16013444 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN HAD DILATED PERCUTANEOUSLY AS USUAL; HOWEVER, WHEN THE PHYSICIAN ADVANCED THE SHEATH AND BEGAN TO DEFLATE THE BALLOON, BLEEDING WAS OBSERVED FROM THE PATIENT. THE BLEEDING WAS CONTROLLED, BUT ANESTHESIA BEGAN WORKING UP THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO REPORTED DEFICIENCY OR MALFUNCTION OF THE NEPHROMAX BALLOON AND IT WAS NOT CLEAR WHETHER THE BALLOON CONTRIBUTED TO THE BLEEDING. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14851575 ↗
• MalfunctionMar 11, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX BALLOON CATHETER KITS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON CATHETER KITS WERE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT WHILE UNPACKING OF THE DEVICE DURING PREPARATION, IT WAS NOTICED THAT BOTH DEVICES LOOK DARK AND DIRTY. A PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THE FOREIGN MATERIAL PRESENT ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER KIT. 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: Insufficient Information

  MAUDE report 11464745 ↗
• MalfunctionMar 11, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX BALLOON CATHETER KITS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON CATHETER KITS WERE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT WHILE UNPACKING OF THE DEVICE DURING PREPARATION, IT WAS NOTICED THAT BOTH DEVICES LOOK DARK AND DIRTY. A PHOTO SUBMITTED BY THE CUSTOMER CONFIRMED THE FOREIGN MATERIAL PRESENT ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER KIT. 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: Insufficient Information

  MAUDE report 11463603 ↗
• MalfunctionFeb 4, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX DILATATION BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE NEPHROSTOMY TRACT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT BOTH BALLOONS BURST. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11278114 ↗
• MalfunctionFeb 4, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX DILATATION BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX DILATATION BALLOON CATHETERS WERE USED IN THE NEPHROSTOMY TRACT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT BOTH BALLOONS BURST. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11278100 ↗
• MalfunctionJan 14, 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 NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BLACK RESIDUE WAS NOTICED ON THE BALLOON UPON OPENING THE PACKAGE. 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 TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171301 ↗
• InjuryAug 18, 2020Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AT THE END OF THE CASE, IT WAS NOTED THAT A SMALL PIECE OF THE RENAL SHEATH DETACHED INSIDE THE PATIENT. REPORTEDLY, THE DETACHED PIECE WAS RETRIEVED USING A BASKET. ADDITIONALLY, THE CLEAR RENAL SHEATH WAS NOTED BENT DUE TO TORQUING AND PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419999 ↗
• MalfunctionDec 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A KIDNEY STONE REMOVAL PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL TIP OF THE CATHETER KINKED WHILE INSERTING INTO THE PATIENT. 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 TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450418 ↗
• MalfunctionOct 17, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER KIT WAS UNPACKED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTED THAT A CREAM COLORED RESIDUE WAS FOUND ON THE BALLOON. REPORTEDLY, THIS WAS FOUND PRIOR TO USE WITH A PATIENT OR PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202137 ↗
• MalfunctionOct 2, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER KIT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BALLOON POPPED AT THE VERY END OF THE PROCEDURE. A PHOTO SENT BY THE CUSTOMER HAS CONFIRMED THAT THE BALLOON RUPTURED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9145042 ↗
• MalfunctionJun 4, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE HAVE BEEN 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 8666486 ↗