NA M0064101030Recalls & reported problems
Boston Scientific Corporation · Malecot Nephrostomy Catheter Set · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729005292), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALECOT NEPHROSTOMY CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, ONE OF THE CATHETER FLAIR RIPPED WHILE INSERTING THE STYLET TO STRAIGHTEN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER MALECOT NEPHROSTOMY CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937854 ↗
Other CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY devices
- NA M0067001210Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 deaths48 reports
- Flexima™ M001271800Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- NA M0064201110Boston 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
- Re-Entry Malecot Nephrostomy Catheter Set M0064101060Boston 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.