NavarreRecalls & reported problems across all models
Bard Access Systems, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,228
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 15 models of Navarre by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,228 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2017 and Sep 30, 2026 — classified as 27 injuries, 1,201 malfunctions.
The most frequently reported specific device problem is “Fracture” (598 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Navarre problems
Device problems
- Fracture598
- Material Separation263
- Break218
- Fluid/Blood Leak182
- Defective Component168
- Crack63
- Nonstandard Device52
- Material Integrity Problem41
Patient problems
- No Clinical Signs, Symptoms or Conditions1,037
- No Consequences Or Impact To Patient70
- No Known Impact Or Consequence To Patient64
- No Patient Involvement35
- Extravasation15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Pain4
- Unspecified Infection2
Navarre models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Navarre NNU8LPTCATHETER, IRRIGATION736 reports
- Navarre NNU6LPTCATHETER, IRRIGATION211 reports
- Navarre NNU10LPTCATHETER, IRRIGATION127 reports
- Navarre NBD8CATHETER, BILIARY, DIAGNOSTIC60 reports
- Navarre NNU12LPTCATHETER, IRRIGATION48 reports
- Navarre NNU8PTCATHETER, IRRIGATION13 reports
- Navarre NNU6LP15CATHETER, IRRIGATION10 reports
- Navarre NBD10CATHETER, BILIARY, DIAGNOSTIC8 reports
- Navarre NNU12PTCATHETER, IRRIGATION4 reports
- Navarre NNU8LP15CATHETER, IRRIGATION3 reports
- Navarre NBD12CATHETER, BILIARY, DIAGNOSTIC2 reports
- Navarre NDB600BAG, BILE COLLECTING2 reports
- Navarre NNU6PTCATHETER, IRRIGATION2 reports
- Navarre NNU6JCATHETER, IRRIGATION1 report
- Navarre NNU8JCATHETER, IRRIGATION1 report
Recent Navarre adverse event reports
The 15 most recent reports across all models, 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 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 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 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre Opti-Drain8 models · 1,197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page