Navarre Opti-Drain NOD10JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741037023), received between Jan 19, 2022 and May 7, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  A PATIENT UNDERWENT FOR HYDROTHORAX PERCUTANEOUS DRAINAGE PROCEDURES UNDER CT GUIDANCE USING NAVARRE OPTI-DRAIN. PRIOR TO THE PROCEDURE, THE PACKAGE WAS FOUND WITH FOREIGN OBJECTS IN THE PACKAGE AND DAMAGE WAS NOTICED INSIDE THE INNER PACKAGING. THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974467 ↗
• MalfunctionMay 7, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  A PATIENT UNDERWENT FOR HYDROTHORAX PERCUTANEOUS DRAINAGE PROCEDURES UNDER COMPUTED TOMOGRAPHY GUIDANCE USING NAVARRE OPTI-DRAIN. PRIOR TO THE PROCEDURE, THE PACKAGE WAS FOUND WITH FOREIGN OBJECTS IN THE PACKAGE AND DAMAGE WAS NOTICED INSIDE THE INNER PACKAGING. THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974466 ↗
• MalfunctionMay 7, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  A PATIENT UNDERWENT FOR HYDROTHORAX PERCUTANEOUS DRAINAGE PROCEDURES UNDER COMPUTED TOMOGRAPHY GUIDANCE USING NAVARRE OPTI-DRAIN. PRIOR TO THE PROCEDURE, THE PACKAGE WAS FOUND WITH FOREIGN OBJECTS IN THE PACKAGE AND DAMAGE WAS NOTICED INSIDE THE INNER PACKAGING. THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974465 ↗
• MalfunctionJan 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THREE DAYS POST CATHETER PLACEMENT, THE DRAINAGE TUBE WAS ALLEGEDLY CRACKED AT THE INTERFACE. REPORTEDLY, RE INSTALLED THE SECOND TUBE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289449 ↗
• MalfunctionJan 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT FIVE DAYS POST CATHETER PLACEMENT, THE TUBE WAS ALLEGEDLY CRACKED AT THE INTERFACE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289446 ↗