NephroMax KitRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NephroMax Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 4 models of NephroMax Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Apr 2, 2026 — classified as 5 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (35 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
NephroMax Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported NephroMax Kit problems
Device problems
- Burst Container or Vessel35
- Material Split, Cut or Torn5
- Device Contamination with Chemical or Other Material4
- Material Integrity Problem4
- Material Puncture/Hole3
- Material Rupture3
- Defective Device2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient6
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information2
- Anxiety1
- Discomfort1
- Fever1
NephroMax Kit models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NephroMax Kit M0062101180CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600CATHETER, NEPHROSTOMY1 recall11 reports
- NephroMax Kit M0062101620CATHETER, NEPHROSTOMY14 reports
- NephroMax Kit M0062101640CATHETER, NEPHROSTOMY6 reports
Recent NephroMax Kit adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionMay 27, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AT 18 ATM. 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 19400895 ↗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 ↗MalfunctionJan 2, 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 NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 18 (ATM) ATMOSPHERIC PRESSURE. 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 18427605 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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