Re-Entry Malecot Nephrostomy Catheter Set M0064101060Recalls & reported problems
Boston Scientific Corporation · Re-Entry Malecot Nephrostomy Catheter Set · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729005308), received between Feb 7, 2019 and Oct 22, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Most reported problems
Device problems
- Break2
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALECOT NEPHROSTOMY CATHETER WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE STERILE PLASTIC PACKAGING OF THE NEPHRO CATHETERS HAS HOLES IN IT.
Patient problems: No Patient Involvement
MAUDE report 9218976 ↗MalfunctionOct 22, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALECOT NEPHROSTOMY CATHETER WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE STERILE PLASTIC PACKAGING OF THE NEPHRO CATHETERS HAS HOLES IN IT.
Patient problems: No Patient Involvement
MAUDE report 9218944 ↗MalfunctionFeb 12, 2019Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, IT WAS NOTED THAT THE CATHETER WAS BROKEN. REPORTEDLY, THIS EVENT HAPPENED FIVE YEARS AGO WITH DR. GILBERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8332383 ↗MalfunctionFeb 7, 2019Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE KIDNEY DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SCHEDULED FOR THE REMOVAL OF THE DRAINAGE CATHETER. REPORTEDLY, AFTER THE PROCEDURE, THE PHYSICIAN FOUND THAT THE CATHETER WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8316365 ↗
Other CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY devices
- NA M0067001210Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 deaths48 reports
- NA M0064201110Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- Flexima™ M001271800Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- Skater™ All-Purpose and Nephrostomy Set 756608025Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery5 reports
- Flexima™ M001271790Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY4 reports
- SKATER™ All Purpose and Nephrostomy Drainage Set 756608035Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery4 reports
- Flexima™ M001271860Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 reports
- SKATER™ All Purpose and Nephrostomy Drainage Set 756606020Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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