Flexima™ M001271820Recalls & reported problems
Boston Scientific Corporation · Nephrostomy Catheter System · 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 08714729323334), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (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
- Packaging Problem1
- Unsealed Device Packaging1
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.
MalfunctionAug 13, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A FLEXIMA CATHETER DRAINAGE WAS RECEIVED WITH ITS PACKAGE DEFECTIVE. A PART OF THE PRODUCT WAS OUTSIDE OF THE PACKAGE, AND A VISIBLE TEAR WAS FOUND IN THE INNER PACKAGING. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972847 ↗
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.