Navarre Opti-DrainRecalls & reported problems across all models
Bard Access Systems, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,197
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 8 models of Navarre Opti-Drain by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,197 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2017 and Sep 16, 2026 — classified as 19 injuries, 1,178 malfunctions.
The most frequently reported specific device problem is “Fracture” (611 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 Opti-Drain problems
Device problems
- Fracture611
- Material Separation250
- Fluid/Blood Leak197
- Break193
- Defective Component170
- Nonstandard Device161
- Material Integrity Problem24
- Suction Problem21
Patient problems
- No Clinical Signs, Symptoms or Conditions1,137
- No Consequences Or Impact To Patient27
- No Known Impact Or Consequence To Patient10
- Extravasation9
- Hemorrhage/Blood Loss/Bleeding7
- Pneumothorax4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Infiltration into Tissue3
Navarre Opti-Drain models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Navarre Opti-Drain NOD8LPTCATHETER, IRRIGATION901 reports
- Navarre Opti-Drain NOD10LPTCATHETER, IRRIGATION178 reports
- Navarre Opti-Drain NOD12LPTCATHETER, IRRIGATION67 reports
- Navarre Opti-Drain NOD8JCATHETER, IRRIGATION24 reports
- Navarre Opti-Drain NOD10PTCATHETER, IRRIGATION10 reports
- Navarre Opti-Drain NOD8PTCATHETER, IRRIGATION10 reports
- Navarre Opti-Drain NOD10JCATHETER, IRRIGATION5 reports
- Navarre Opti-Drain NOD12PTCATHETER, IRRIGATION2 reports
Recent Navarre Opti-Drain adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break; Material Separation
On (b)(6)2026, a patient underwent a ultrasound guided percutaneous percutaneous drainage catheter placement procedure using Navarre Opti Drain Drainage Catheter. During the procedure, the Sure LokTM thread was allegedly broken. The affected drainage catheter was replaced with a new drainage catheter, and the procedure was completed successfully. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784560 ↗MalfunctionSep 16, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent a ultrasound guided percutaneous percutaneous drainage catheter placement procedure using Navarre Opti Drain Drainage Catheter. During the procedure, the Sure LokTM thread was allegedly broken. The affected drainage catheter was replaced with a new drainage catheter, and the procedure was completed successfully. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784559 ↗MalfunctionSep 14, 2026Fluid/Blood Leak; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751222 ↗MalfunctionSep 14, 2026Nonstandard Device
On (b)(6) 2026, a patient was scheduled to undergo an ultrasound guided ascites percutaneous drainage procedure using a Navarre Opti Drain Drainage Catheter. Prior to the procedure, it was noted that the trocar needle length was excessively 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 50750200 ↗MalfunctionSep 14, 2026Nonstandard Device
On (b)(6)2026, a patient was scheduled to undergo an ultrasound guided ascites percutaneous drainage procedure using a Navarre Opti Drain Drainage Catheter. Prior to the procedure, it was noted that the trocar needle length was excessively 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 50750199 ↗MalfunctionSep 14, 2026Nonstandard Device
On (b)(6) 2026, a patient was scheduled to undergo an ultrasound guided ascites percutaneous drainage procedure using a Navarre Opti Drain Drainage Catheter. Prior to the procedure, it was noted that the trocar needle length was excessively 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 50750196 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749384 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749381 ↗MalfunctionSep 14, 2026Break; Material Separation
On (b)(6) 2026, a patient underwent an ultrasound guided abscess percutaneous drainage procedure using the Navarre Opti Drain Drainage Catheter. Prior to the procedure, the thread was found to have completely separated from the catheter. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749380 ↗MalfunctionSep 8, 2026Break; Material Separation
On (b)(6) 2026, the patient underwent a CT scan guided percutaneous drainage catheter placement procedure using Navarre Opti Drain Drainage Catheter. During the procedure, it was reported that Sure Lok thread was broken. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50666491 ↗MalfunctionSep 8, 2026Fracture
On (b)(6) 2026, a patient underwent an ultrasound guided Percutaneous Transhepatic Cholangial Drainage procedure using the Navarre Opti Drain Drainage Catheter. After the procedure, the drainage catheter connector fractured. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50665183 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
A patient underwent an ultrasound guided ascites percutaneous drainage catheter placement procedure using a Navarre Opti Drain Catheter. Following the procedure on (b)(6) 2026, fluid leakage was observed from the small hole of the Sure-Lok component. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565717 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565715 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565714 ↗MalfunctionSep 2, 2026Fracture
A patient underwent a computed tomography guided hydrothorax percutaneous drainage catheter placement procedure using a Navarre Opti Drain Catheter. Post the procedure on (b)(6) 2026, it was noted that the drainage catheters connector was found to be fractured. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50560483 ↗
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
- Navarre15 models · 1,228 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 18, 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