Navarre NNU6LP15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741036965), received between Jul 27, 2018 and Nov 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  A PATIENT UNDERWENT FOR CHRONIC CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN. DURING THE DRAINAGE CATHETER PLACEMENT PROCEDURE, THE GUIDE WIRE FAILED TO PASS THROUGH PROPERLY AND EXPERIENCED TEARING DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519980 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  ON (B)(6) 2025 IT WAS REPORTED THAT DURING A DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LOCKING DRAINS WAS ALLEGEDLY FOUND LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628553 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Component Misassembled; Fluid/Blood Leak; Component Misassembled

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LOCKING DRAINS WAS ALLEGEDLY FOUND LEAKAGE. T WAS FURTHER REPORTED THAT THE THREAD WAS ALLEGEDLY GETTING CAUGHT IN THE SCREW THREADS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628526 ↗
• MalfunctionJun 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A DRAINAGE CATHETER PLACEMENT PROCEDURE, THE WHITE HUB OF THE CATHETER WAS ALLEGEDLY CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207927 ↗
• MalfunctionJan 16, 2020Crack; Crack

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL NNU6LP15 DRAINAGE CATHETER ALLEGEDLY EXPERIENCED A CRACK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596041 ↗
• MalfunctionDec 27, 2018Crack; Defective Component; Crack; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY CRACKED. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200262 ↗
• MalfunctionDec 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY CRACKED. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200253 ↗
• MalfunctionDec 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY CRACKED. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200167 ↗
• MalfunctionDec 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS ALLEGEDLY CRACKED. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199925 ↗
• MalfunctionJul 27, 2018Crack; Crack

  IT WAS REPORTED THAT AN CRACK WAS ALLEGEDLY FOUND IN THE HUB, WHICH LED TO AN AIR LEAK OF THE DRAINAGE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728320 ↗