NephroMax M0062101440Recalls & reported problems
Boston Scientific Corporation · High Pressure Nephrostomy Balloon Catheter · Class U
All models of NephroMax (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729826507), received between Aug 23, 2017 and Jul 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
- Material Deformation1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionFeb 26, 2020Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY CATHETER BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS BENDING AT THE TOP. REPORTEDLY, THE BALLOON WAS REMOVED AND INSPECTED, IT WAS NOTICED THAT THE BALLOON LOOKED UNUSUAL. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9756171 ↗MalfunctionAug 23, 2017Material Rupture; Material Rupture
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON WAS USED IN THE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE INFLATION, THE BALLOON BURST. THERE WERE NO PIECES OF THE BALLOON THAT DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON. 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 6812783 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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