Navarre NNU6LPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 00801741000348), received between Jul 26, 2017 and Sep 14, 2026 — classified as 3 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Fracture” (99 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 25 most recent of 211 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Material Separation

  On (b)(6)2026, a patient underwent an ultrasound guided hydrothorax percutaneous drainage procedure using a Navarre Universal Drainage Catheter. During the procedure, the Sure-Lok thread detached at the pigtail portion of the catheter. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750643 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak

  On (b)(6) 2026, a patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (PTCD) catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that leakage was observed from a small hole in the Sure-Lok component during drainage. The procedure was successfully completed using a replacement device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730781 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak

  On (b)(6) 2026, a patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (PTCD) catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that leakage was observed from a small hole in the Sure-Lok component during drainage. The procedure was successfully completed using a replacement device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730780 ↗
• MalfunctionSep 4, 2026Fluid/Blood Leak; Fracture

  On August 10, 2026, a patient underwent an ultrasound guided Percutaneous Transhepatic Cholangial Drainage procedure using the Navarre Universal Drainage Catheter. On (b)(6) 2026, the drainage catheter connector fractured into two pieces. It was further reported that leakage was noted. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50606105 ↗
• MalfunctionSep 4, 2026Fluid/Blood Leak; Fracture; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50606103 ↗
• MalfunctionJun 4, 2026Difficult to Insert; Nonstandard Device

  ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE FRONT HOLE OF THE DRAINAGE TUBE WAS TOO NARROW TO ALLOW NORMAL INSERTION OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387301 ↗
• MalfunctionJun 3, 2026Nonstandard Device

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE; IT WAS NOTED THAT THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER TOO MUCH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25372776 ↗
• MalfunctionMay 18, 2026Break; Material Separation; Device Dislodged or Dislocated

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. DURING THE PROCEDURE, THE SURE LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197326 ↗
• MalfunctionMay 7, 2026Break; Material Separation; Improper or Incorrect Procedure or Method

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE SURE LOK THREAD WAS BROKEN. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE THREAD, AND NO VISIBLE GLUE WAS OBSERVED AT THE END OF THE DISENGAGED THREAD. AS A RESULT, THE AFFECTED DRAINAGE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109299 ↗
• MalfunctionApr 24, 2026Break; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A PTCD DRAINAGE PROCEDURE UNDER ULTRASOUND GUIDANCE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE DRAINAGE PROCESS, THE SILK SUTURE ASSOCIATED WITH THE LOCKING DEVICE PULLED OFF. THE DAMAGED COMPONENT WAS IDENTIFIED AS THE LOCKING DEVICE SUTURE. THE SUTURE WAS NOT OVERSTRETCHED, AND NO GLUE WAS VISIBLE AT THE END OF THE DISLODGED WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980180 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN CATHETER. POST THE PROCEDURE ON (B)(6) 2026, LEAKAGE WAS OBSERVED FROM A SMALL HOLE IN THE SURE-LOK TM COMPONENT, SPECIFICALLY INVOLVING DAMAGE TO THE SURE-LOK TM THREAD. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951685 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN CATHETER. POST THE PROCEDURE ON (B)(6) 2026, LEAKAGE WAS OBSERVED FROM A SMALL HOLE IN THE SURE-LOK TM COMPONENT, SPECIFICALLY INVOLVING DAMAGE TO THE SURE-LOK TM THREAD. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951684 ↗
• MalfunctionApr 13, 2026Break; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED HYDROPERICARDIUM PERCUTANEOUS DRAINAGE PROCEDURE USING A NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PROCEDURE, THE SURE-LOK TM THREAD WAS OBSERVED TO HAVE DIGRESSED FROM THE PIGTAIL. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE THREAD, AND NO GLUE WAS VISIBLE AT THE END OF THE DISLODGED THREAD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854194 ↗
• MalfunctionApr 6, 2026Difficult to Insert; Nonstandard Device

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. BEFORE THE DRAIN WAS PLACED, IT WAS IDENTIFIED THAT THE HOLE AT THE TUBING TIP WAS TOO THIN TO ALLOW PASSAGE OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788823 ↗
• MalfunctionMar 30, 2026Break; Material Separation

  THE PATIENT UNDERWENT AN ULTRASOUND-GUIDED ASCITES PERCUTANEOUS DRAINAGE PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. POST THE PROCEDURE ON (B)(6) 2026, THE SURE LOK TM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726545 ↗
• MalfunctionMar 24, 2026Nonstandard Device

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL 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 24678946 ↗
• MalfunctionMar 24, 2026Nonstandard Device

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL 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 24672165 ↗
• MalfunctionMar 24, 2026Nonstandard Device

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL 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 24672162 ↗
• MalfunctionMar 18, 2026Nonstandard Device

  ON (B)(6), 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND-GUIDED HYDROPERICARDIUM PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS IDENTIFIED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SUBSTANTIALLY LONGER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629496 ↗
• MalfunctionMar 18, 2026Packaging Problem

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAIN. DURING PACKAGE INSPECTION, IT WAS REPORTED THAT THE PACKAGE WAS FOUND TO BE DAMAGED, AND THE PACKAGING WAS LEAKING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625072 ↗
• MalfunctionMar 18, 2026Nonstandard Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A PLANNED ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIAL DRAINAGE (PTCD) PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE CLINICAL TEAM IDENTIFIED THAT THE LENGTH OF THE TROCAR NEEDLE WAS MUCH LONGER THAN THE CATHETER DURING PACKAGE AND PRODUCT INSPECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624903 ↗
• MalfunctionMar 3, 2026Fracture; Material Separation

  A PATIENT UNDERWENT A DSA GUIDED PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE, ON (B)(6) 2026, THE DRAINAGE CATHETER CONNECTOR WAS FOUND TO BE FRACTURED. THE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494629 ↗
• MalfunctionFeb 11, 2026Nonstandard Device; Blocked Connection

  ON (B)(6) 2026. A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS NEPHROSTOMY (PCN) PROCEDURE. PRIOR TO THE PROCEDURE, THE CLINICAL TEAM INSPECTED THE PACKAGE AND IDENTIFIED THAT THE DRAINAGE TUBE INTERFACE COULD NOT BE SCREWED PROPERLY DUE TO AN ISSUE WITH THE INTERFACE COMPONENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311823 ↗
• MalfunctionFeb 11, 2026Fracture

  THE PATIENT UNDERWENT AN ULTRASOUND-GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAIN CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311711 ↗
• MalfunctionJan 30, 2026Break; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT FOR AN ULTRASOUND GUIDED PTCD PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN. SOMETIMES POST ULTRASOUND GUIDED PTCD PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE SURE LOK TM THREAD ALLEGEDLY HAD DIGRESSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219259 ↗