NephroMax Kit M0062101180Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729077589), received between May 16, 2017 and Jun 5, 2025 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING DILATION, THE NEPHROMAX BALLOON RUPTURED AT 20 ATMOSPHERES (ATM) INSIDE THE PATIENT WHEN THE RENAL SHEATH WAS INSERTED. THE SAME ISSUE OCCURRED WITH THE SECOND NEPHROMAX BALLOON. THE PROCEDURE WAS COMPLETED WITH GRADUAL RENAL DILATION SYSTEM WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO NEPHROMAX DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152271 ↗
• MalfunctionJun 5, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING DILATION, THE NEPHROMAX BALLOON RUPTURED AT 20 ATMOSPHERES (ATM) INSIDE THE PATIENT WHEN THE RENAL SHEATH WAS INSERTED. THE SAME ISSUE OCCURRED WITH THE SECOND NEPHROMAX BALLOON. THE PROCEDURE WAS COMPLETED WITH GRADUAL RENAL DILATION SYSTEM WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO NEPHROMAX DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152109 ↗
• MalfunctionMay 16, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE WITH THIS NEPHROMAX NEPHROSTOMY BALLOON CATHETER, THE DEVICE WAS WEAK AT MAXIMUM INFLATION, AND IT ALSO RUPTURED. NO FURTHER INFORMATION WAS REPORTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337533 ↗
• MalfunctionMay 16, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE WITH THIS NEPHROMAX NEPHROSTOMY BALLOON CATHETER, THE DEVICE WAS WEAK AT MAXIMUM INFLATION AND IT RUPTURED; ADDITIOANLLY, IT WAS SAID THAT THERE WAS A BLEEDING AS CAUSE OF THIS EVENT. NO FURTHER INFORMATION WAS REPORTED AND THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19337529 ↗
• MalfunctionDec 11, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS INFLATED; HOWEVER, IT POPPED OPEN DUE TO A RUPTURE. 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 18306717 ↗
• MalfunctionDec 6, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON BURST AT 20 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE ANOTHER NEPHROMAX BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924180 ↗
• MalfunctionSep 12, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO 1 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406987 ↗
• MalfunctionJun 29, 2022Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, BOTH BALLOONS BURST BEFORE REACHING TO 20 ATM. 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 14860201 ↗
• MalfunctionJun 29, 2022Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX NEPHROSTOMY BALLOON CATHETERS WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, BOTH BALLOONS BURST BEFORE REACHING TO 20 ATM. 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 14858762 ↗
• MalfunctionApr 20, 2022Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS PIERCED AND COULD NOT BE USED IN A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON KIT. 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. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159597 ↗
• InjuryNov 3, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST AND THE PHYSICIAN HAD TO RETRIEVE THE FRAGMENTS OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON. THE PATIENT OUTCOME WAS REPORTED TO BE FULLY RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746445 ↗
• InjurySep 13, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED HOWEVER; IT WAS NOTICED THAT THE BALLOON BURST AT 18 ATM. REPORTEDLY, THE BALLOON WAS REMOVED AND A PERFORATION WAS NOTED ON THE PATIENTS RENAL PELVIS. THE PERFORATION WAS CONFIRMED WITH A CT SCAN AND NO FURTHER ACTION WAS TAKEN TO TREAT THE PERFORATION AS IT IS BELIEVED TO HEAL ON ITS OWN; HOWEVER, THE HOSPITAL STAY WAS EXTENDED TO MONITOR THE PATIENT STATUS. THE PROCEDURE WAS COMPLETED WITH A RETROGRADE STENT. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT HAD A FEVER BUT IT EVENTUALLY SUBSIDED. THE PATIENT WAS THEN DISCHARGED AFTER A FEW DAYS.

  Patient problems: Fever; Perforation

  MAUDE report 12459177 ↗
• MalfunctionMay 12, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX BALLOON KIT USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON KITS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, BOTH BALLOONS BURST WHEN INFLATED. THERE WERE NO PATIENT COMPLICATIONS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11812005 ↗
• MalfunctionMay 12, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX BALLOON KIT USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NEPHROMAX BALLOON KITS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, BOTH BALLOONS BURST WHEN INFLATED. THERE WERE NO PATIENT COMPLICATIONS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11812004 ↗
• MalfunctionMar 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER KIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON SPLIT OPEN UPON SECOND INFLATION WHICH INCREASED THE BLEEDING ON THE PATIENT. REPORTEDLY, THE BLEEDING WAS CONTROLLED AND THERE WERE NO FURTHER PATIENT COMPLICATIONS 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11580933 ↗
• InjuryFeb 15, 2021Difficult to Insert; Defective Device; Material Deformation; Appropriate Device Problem Term/Code Not Available; Difficult to Insert; Defective Device; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT WAS ON ITS 5 WEEKS POST-PARTUM AND WAS BREASTFEEDING AN INFANT, THUS REQUIRING LONGER ANESTHETIC TIME AND MORE INVASIVE ACTION DURING THE PROCEDURE. THE PHYSICIAN WAS LOOKING TO MINIMIZE ANESTHETIC, SURGICAL TIME AND TRAUMA WITH FAST ACCESS. DILATION WAS PERFORMED USING A NEPHROMAX BALLOON KIT; HOWEVER, IT WAS NOTICED THAT IT IS NOT POSSIBLE TO VISUALIZE THE DEVICE UNDER IMAGING WHEN A RENAL SHEATH WAS ADVANCED OVER THE BALLOON. ADDITIONALLY, THE TIP OF THE SHEATH WAS KINKED AND COULD NOT REACH THE STONE SITE. REPORTEDLY, THE DEVICE WAS INSERTED REPETEADLY INTO THE PATIENT WHICH CAUSED PROCEDURAL DELAY, MORE TRAUMA AND BLEEDING. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. PHYSICIAN CONCLUDED THAT THE SHEATH MAY HAVE BEEN IMPACTED WITH THE STONE THAT IS WHY IT WAS NOT VISIBLE UNDER IMAGING. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. HOWEVER, THE PATIENT WOULD REQUIRE ADDI

  Patient problems: Anxiety; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Tissue Injury

  MAUDE report 11327259 ↗
• MalfunctionOct 5, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE FATIGUED AND RUPTURED AT 16ATM. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10626448 ↗
• MalfunctionDec 13, 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 RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SAME BALLOON WAS USED TO PROCEED TO A SECOND ACCESS DILATATION AND WHILE INFLATING THE BALLOON BURST. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468984 ↗
• MalfunctionDec 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE SPLIT. 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 9457320 ↗
• MalfunctionNov 5, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION CATHETER BALLOON WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) WITH DILATATION PROCEDURE PERFORMED IN THE KIDNEY ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN ATTEMPTED TO BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION CATHETER BALLOON. 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. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION CATHETER BALLOON WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) WITH DILATATION PROCEDURE PERFORMED IN THE KIDNEY ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281187 ↗
• MalfunctionSep 3, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8955148 ↗
• MalfunctionAug 20, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHILE PUSHING THE OVERSHEATH OVER THE BALLOON. REPORTEDLY, THE PHYSICIAN WAS INSTRUCTED THAT THE MAXIMUM ATMOSPHERIC PRESSURE OF THE NEPHROMAX BALLOON IS 20 ATM; HOWEVER, THE PHYSICIAN STILL INFLATED THE BALLOON TO 24 ATM TO REMOVE THE WAIST ON IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911235 ↗
• MalfunctionJul 9, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON KIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT A LONG HAIR WAS WRAPPED IN AND AROUND THE INFLATION DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT. 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 8771013 ↗
• MalfunctionMar 26, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE. 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 8453027 ↗
• MalfunctionMay 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED ON A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THERE WAS NO PIECE OF THE BALLOON DETACHED INSIDE 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568567 ↗