Navarre Opti-Drain NOD10LPTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Opti-Drain Multi-Use Drainage Catheter, Locking Pigtail, 10 Fr x 30 cm · Class 1
All models of Navarre Opti-Drain (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Navarre Opti-Drain is a drainage catheter with a locking pigtail tip. Many of its 189 reports describe parts that fractured, broke, or separated, along with some fluid leaks. Most reports describe no effect on patients. There are no injuries and no deaths. No recalls name this device. Reports rose from 27 in the year before to 78 in the latest year.
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
- 178
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 00801741037030), received between Jan 17, 2018 and Sep 16, 2026 — classified as 178 malfunctions.
The most frequently reported specific device problem is “Fracture” (56 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.
Reports received per month
Most reported problems
Device problems
- Fracture56
- Nonstandard Device48
- Break39
- Defective Component34
- Material Separation33
- Fluid/Blood Leak13
- Crack8
- Deformation Due to Compressive Stress2
Patient problems
- No Clinical Signs, Symptoms or Conditions167
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 178 reports, 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, 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 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 ↗MalfunctionAug 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205714 ↗MalfunctionJul 1, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES USING THE NAVARRE OPTI DRAIN PERFORMED UNDER ULTRASOUND GUIDANCE. PRIOR TO THE PROCEDURE IT WAS IDENTIFIED THAT THE TROCAR NEEDLE LENGTH WAS SIGNIFICANTLY LONGER THAN THE ASSOCIATED CATHETER, RESULTING IN A MISMATCH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25675506 ↗MalfunctionMay 26, 2026Fracture; Material Separation
THE PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. IT WAS REPORTED THAT POST THE PROCEDURE ON (B)(6) 2026, IT WAS NOTED 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 25273910 ↗MalfunctionMay 13, 2026Fracture; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES UNDER ULTRASOUND GUIDANCE USING THE NAVARRE OPTI DRAIN DRAINAGE CATHETER. DURING THE PROCEDURE, A FRACTURE OF THE DRAINAGE CATHETER CONNECTOR WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157107 ↗MalfunctionMay 13, 2026Fracture; Material Separation
THE PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE ON (B)(6) 2026, A FRACTURE OF THE DRAINAGE CATHETER CONNECTOR WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157105 ↗MalfunctionMay 13, 2026Fracture
THE PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE ON APR 22, 2026, A FRACTURE OF THE DRAINAGE CATHETER CONNECTOR WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157103 ↗MalfunctionMay 12, 2026Fracture
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. POST PROCEDURE, IT WAS NOTED THAT THE DRAINAGE CATHETERS CONNECTOR HAD FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148265 ↗MalfunctionApr 30, 2026Break; Fluid/Blood Leak; Material Separation
ON (B)(6) 2026, THE PATIENT UNDERWENT A ULTRASOUND GUIDED CYSTIC DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN. POST PROCEDURE, IT WAS NOTED THAT THE SUTURE OF THE LOCKING DEVICE HAD FALLEN OFF AT THE PIGTAIL PORTION OF THE DRAIN. THE ISSUE INVOLVED SEPARATION OF THE LOCKING DEVICE SUTURE ONLY, WITH NO VISIBLE GLUE OBSERVED AT THE END OF THE DISLODGED THREAD. THERE WAS NO REPORT OF EXCESSIVE OR OBVIOUS PULLING FORCE APPLIED PRIOR TO THE SUTURE DISLODGEMENT OR FAILURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25041013 ↗MalfunctionApr 30, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2026, THE PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTIDRAIN. POST PROCEDURE, IT WAS OBSERVED THAT THE DRAINAGE CATHETER CONNECTOR HAD FRACTURED. IT WAS CONFIRMED THAT THE CONNECTOR HAD NOT COME INTO CONTACT WITH ALCOHOL PRIOR TO THE FRACTURE, AND LEAKAGE OF FLUID 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 25041010 ↗MalfunctionApr 28, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY 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 25019184 ↗MalfunctionApr 28, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY 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 25019138 ↗MalfunctionApr 18, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. AFTER THE DRAINAGE WAS COMPLETED, A FRACTURE WAS NOTED IN THE DRAINAGE TUBE CONNECTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919257 ↗MalfunctionApr 18, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. AFTER THE DRAINAGE WAS COMPLETED, A FRACTURE WAS NOTED IN THE DRAINAGE TUBE CONNECTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919254 ↗MalfunctionApr 17, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PLEURAL FLUID DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE CANNULA NEEDLE TIP WAS TOO LONG, EXTENDING BEYOND THE DRAINAGE TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909447 ↗MalfunctionApr 17, 2026Nonstandard Device
ON (B)(6) , 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PLEURAL FLUID DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE CANNULA NEEDLE TIP WAS TOO LONG, EXTENDING BEYOND THE DRAINAGE TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908625 ↗MalfunctionApr 17, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN THROUGH AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SHORTER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906747 ↗MalfunctionApr 17, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN THROUGH AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SHORTER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906745 ↗MalfunctionApr 17, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN THROUGH AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SHORTER THAN THE ASSOCIATED DRAINAGE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906743 ↗MalfunctionApr 6, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT PREPPED FOR AN ULTRASOUND-GUIDED ASCITES PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, IT WAS IDENTIFIED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SIGNIFICANTLY 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 24788827 ↗
Other CATHETER, IRRIGATION devices
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- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
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- BLAKE 2229Ethicon Inc. · CATHETER, IRRIGATION76 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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