Navarre NNU8PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741037016), received between Jul 19, 2019 and Jun 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Restricted Flow rate

  ON J(B)(6) 2026, THE PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE, IT WAS OBSERVED THAT THE DRAINAGE WAS SIGNIFICANTLY SLOWER THAN EXPECTED, WITH THE DEVICE USED IN THE PERITONEUM AND GRAVITY FLOW UTILIZED FOR DRAINAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618614 ↗
• MalfunctionMay 14, 2026Collapse; Restricted Flow rate; Obstruction of Flow

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE DURING USE OF A NAVARRE DRAINAGE DEVICE. DURING THE PROCEDURE, OCCLUSIONS WERE ENCOUNTERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172001 ↗
• MalfunctionNov 25, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643562 ↗
• MalfunctionNov 25, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643560 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630265 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629861 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629857 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Nonstandard Device

  ON 31 OCTOBER 2025, IT WAS REPORTED THAT DURING PREPARATION OF A HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601888 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Nonstandard Device

  ON (B)(6) 2025, A PATIENT WAS PREPPED FOR A OF A HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAIN. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601885 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Nonstandard Device

  ON 31 OCTOBER 2025, IT WAS REPORTED THAT DURING PREPARATION OF A HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601753 ↗
• MalfunctionJan 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL NNU8PT. CHRONIC CATHETER ALLEGEDLY EXPERIENCE FLUID BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVE PATIENT WITH NO REPORTED PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9593300 ↗
• MalfunctionJul 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENT INDICATED THAT MODEL NNU8PT EXPERIENCED A FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818410 ↗
• MalfunctionJul 19, 2019Break; Crack; Break; Crack

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL NNU8PT DRAINAGE CATHETER ALLEGEDLY BROKE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809536 ↗