Navarre NNU8LPTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Universal Drainage Catheter with Nitinol, Locking Pigtail, 8 Fr x 30 cm · Class 1
Quick summary
This Bard Navarre Universal drainage catheter has 754 reports, with no deaths and 18 injuries. Most reports describe the catheter fracturing or breaking, often at its connector, and some describe material separating or fluid leaking out. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 736
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 736 adverse event reports that list this exact device (DI 00801741037009), received between Mar 22, 2017 and Sep 30, 2026 — classified as 18 injuries, 718 malfunctions.
The most frequently reported specific device problem is “Fracture” (390 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.
Reports received per month
Most reported problems
Device problems
- Fracture390
- Material Separation169
- Fluid/Blood Leak129
- Break101
- Defective Component99
- Crack37
- Material Integrity Problem28
- Nonstandard Device25
Patient problems
- No Clinical Signs, Symptoms or Conditions671
- No Consequences Or Impact To Patient25
- No Known Impact Or Consequence To Patient24
- Extravasation11
- No Patient Involvement4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Unspecified Infection2
- Abdominal Pain1
Recent adverse event reports
The 25 most recent of 736 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Integrity Problem
It was reported that on (b)(6) 2026, during a gallbladder surgery procedure, a single use drainage catheter was selected for use. Upon opening the sterile package, the healthcare professional observed that the suture attached to the catheter was damaged. As a result, the device did not meet the requirements for intraoperative use and could not be used as intended. The affected device was immediately removed from use, and a replacement drainage catheter was obtained to continue the procedure. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944182 ↗MalfunctionSep 28, 2026Fracture; Material Separation
A patient underwent an ultrasound guided percutaneous transhepatic cholangiography drainage (PTCD) catheter placement procedure using the Navarre Universal Drainage Catheter. Following the procedure, on (b)(6) 2026, it was reported that the drainage catheter connector had fractured. The catheter was subsequently replaced, and the procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910914 ↗MalfunctionSep 24, 2026Break; Material Separation
On (b)(4) 2026, a patient underwent an ultrasound guided percutaneous drainage catheter placement procedure using Navarre Universal Drainage Catheter. Prior to the procedure, the wire is disconnected at the from the pigtail. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881315 ↗MalfunctionSep 24, 2026Nonstandard Device
On (b)(6) 2026, a patient underwent an ultrasound guided cyst drainage catheter placement procedure using Navarre Universal Drainage Catheter. Prior to the procedure, it was noted that the trocar needle was shorter in length 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 50877870 ↗MalfunctionSep 21, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent a computed tomography guided percutaneous transhepatic cholangiography drainage (PTCD) catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that the Sure-Lok thread completely disengaged from 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 50837140 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
On (b)(6) 2026, a patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that leakage was observed from the drainage catheter. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713087 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
On (b)(6) 2026, a patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that leakage was observed from the drainage catheter. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713080 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
On (b)(6)2026, a patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a Navarre Universal Drainage Catheter. During the procedure, it was reported that leakage was observed from the drainage catheter. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713079 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
On (b)(6) 2026, a patient underwent an ultrasound guided ascites percutaneous drainage procedure using a Navarre Universal Drainage Catheter. It was reported that during the procedure, 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 50689902 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
On (b)(6) 2026, a patient underwent an ultrasound guided ascites percutaneous drainage procedure using a Navarre Universal Drainage Catheter. It was reported that during the procedure, 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 50689900 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688754 ↗MalfunctionSep 7, 2026Fracture
A patient underwent an ultrasound guided ascites percutaneous drainage procedure using a Navarre Universal Drainage Catheter. On (b)(6) 2026, the drainage catheter connector was found to be fractured. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650591 ↗MalfunctionSep 7, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650588 ↗MalfunctionSep 7, 2026Fracture; Material Separation
A patient underwent an ultrasound guided ascites percutaneous drainage procedure using a Navarre Universal Drainage Catheter. On (b)(6) 2026, the drainage catheter connector was found to be fractured. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649815 ↗MalfunctionSep 7, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649100 ↗MalfunctionJun 26, 2026Fluid/Blood Leak; Fracture; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE, THE DRAINAGE CATHETER CONNECTOR WAS REPORTEDLY FRACTURED AND LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633692 ↗MalfunctionJun 23, 2026Fracture; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST THE PROCEDURE, 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 25590266 ↗MalfunctionJun 23, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST THE PROCEDURE, 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 25590128 ↗MalfunctionJun 9, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT SURE LOK THREAD WAS ALLEGEDLY DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25440052 ↗MalfunctionJun 3, 2026Break; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE UNIVERSAL DRAINAGE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THAT THE SURE LOK THREAD WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372192 ↗MalfunctionJun 3, 2026Break; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THAT THE SURE LOK THREAD WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372189 ↗MalfunctionMay 25, 2026Fracture; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE, IT WAS NOTED THAT THE DRAINAGE CATHETERS CONNECTOR WAS FRACTURED AND SHATTERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267807 ↗MalfunctionMay 20, 2026Fracture; Material Separation
THE PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED THAT THE DRAINAGE CATHETER CONNECTOR WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225963 ↗MalfunctionMay 13, 2026Fluid/Blood Leak
THE PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) CATHETER PLACEMENT PROCEDURE USING A NAVARRE UNIVERSAL DRAINAGE CATHETER. POST THE PROCEDURE ON (B)(6) 2026, IT WAS OBSERVED THAT THERE WAS LEAKAGE FROM THE SMALL HOLE OF THE SURE-LOK TM COMPONENT OF THE DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157834 ↗MalfunctionMay 12, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE, ON (B)(6) 2026, THE PATIENT¿S FAMILY REPORTED FLUID LEAKAGE AT THE CATHETER CONNECTION SITE. IT WAS ALSO REPORTED THAT THE CONNECTOR HAD FRACTURED, RESULTING IN BILE LEAKAGE, AND THE DRAINAGE CATHETER OUTLET WAS NO LONGER ABLE TO CONNECT TO THE SPIRAL TUBING TO FACILITATE DRAINAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149573 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.