Navarre Opti-Drain NOD8JRecalls & reported problems
Bard Access Systems, Inc. · Navarre Opti-Drain Multi-Use Drainage Catheter, J-Curve, 8 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 used to drain fluid collections. The 24 reports describe parts not fitting as expected, such as mismatched needle and catheter lengths or a metal sleeve that stuck, and catheters that were hard to insert, stuck, or broke, with procedures finished using another device. There are no deaths and no injuries, and no recalls name this device. Reports rose to 13 in the last 12 months from 5 in the prior 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741037085), received between Oct 29, 2020 and Aug 27, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (10 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
- Nonstandard Device10
- Fracture9
- Difficult to Remove8
- Defective Component2
- Difficult to Insert1
- Fluid/Blood Leak1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Nonstandard Device
On (b)(6) 2026, the patient underwent an ultrasound guided abscess percutaneous drainage catheter placement procedure using Navarre Opti Drain Drainage Catheter. Prior to the procedure, it was noted that the length of trocar needle was shorter 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 50467570 ↗MalfunctionJun 11, 2026Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN FOR A CYST. DURING THE PROCEDURE, THE METAL SLEEVE COULD NOT BE PULLED OUT AND COULD NOT BE SEPARATED FROM THE PIPE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25467982 ↗MalfunctionJun 11, 2026Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN FOR A CYST. DURING THE PROCEDURE, THE METAL SLEEVE COULD NOT BE PULLED OUT AND COULD NOT BE SEPARATED FROM THE PIPE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25467979 ↗MalfunctionJun 11, 2026Difficult to Remove
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN FOR A CYST. DURING THE PROCEDURE, THE METAL SLEEVE COULD NOT BE PULLED OUT AND COULD NOT BE SEPARATED FROM THE PIPE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25467976 ↗MalfunctionFeb 25, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN PLACEMENT PROCEDURE UNDER ULTRASOUND GUIDANCE. PRIOR TO THE PROCEDURE THE CLINICAL TEAM INSPECTED THE PACKAGE AND IDENTIFIED THAT THE TROCAR NEEDLE 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 24439221 ↗MalfunctionFeb 25, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN PLACEMENT PROCEDURE UNDER ULTRASOUND GUIDANCE. PRIOR TO THE PROCEDURE THE CLINICAL TEAM INSPECTED THE PACKAGE AND IDENTIFIED THAT THE TROCAR NEEDLE 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 24439219 ↗MalfunctionFeb 16, 2026Material Integrity Problem; Physical Resistance/Sticking
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR HYDROTHORAX USING THE NAVARRE OPTI DRAIN. DURING THE PROCEDURE, THE CLINICIAN IDENTIFIED THAT THE TUBE BODY EXHIBITED ASTRINGENCY, AFFECTING ITS NORMAL FUNCTIONALITY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24342156 ↗MalfunctionJan 28, 2026Difficult to Insert; Nonstandard Device
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE OPTI DRAIN CATHETER. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE CATHETER DID NOT FIT AND THE INSERTION WAS DIFFICULT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198284 ↗MalfunctionJan 7, 2026Nonstandard Device; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PIPE WALL AND THE INNER SUPPORT PIPE ARE ALLEGEDLY TOO TIGHT TO BE PULLED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987198 ↗MalfunctionJan 7, 2026Nonstandard Device; Difficult to Remove
ON (B)(6) 2025,A PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PIPE WALL AND THE INNER SUPPORT PIPE ARE ALLEGEDLY TOO TIGHT TO BE PULLED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987193 ↗MalfunctionJan 7, 2026Nonstandard Device; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PIPE WALL AND THE INNER SUPPORT PIPE ARE ALLEGEDLY TOO TIGHT TO BE PULLED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23986730 ↗MalfunctionJan 5, 2026Nonstandard Device; Difficult to Remove
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN. IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES UNDER ULTRASOUND GUIDANCE, THE DRAINAGE TUBE COULD NOT BE PULLED OUT FROM THE INNER SUPPORT TUBE BECAUSE THE TUBE WALL WAS TOO TIGHTLY ATTACHED. THE PROCEDURE WAS COMPLETED BY REPLACING THE DRAINAGE SET WITH A NEW ONE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954510 ↗MalfunctionDec 11, 2025Difficult to Remove; Difficult to Remove
ON (B)(6), THE PATIENT WAS SCHEDULED FOR AN ULTRASOUND-GUIDED THORACENTESIS. UPON OPENING THE CATHETER, THE NEEDLE CORE WAS FOUND TO BE STUCK AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775306 ↗MalfunctionSep 16, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
ON (B)(6) 2025, A PATIENT WAS GETTING PREPARED FOR AN ULTRASOUND GUIDED ASCITES PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI-DRAIN DRAINAGE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY FOUND LONGER THAN CATHETER TOO MUCH. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23060665 ↗MalfunctionAug 26, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
ON (B)(6) 2025, A PATIENT PREPPED FOR AN ULTRASOUND GUIDED CYST PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY FOUND SHORTER 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 22892292 ↗MalfunctionMay 13, 2025Fracture; Fracture
ON(B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST A CATHETER PLACEMENT, THE DRAINAGE CATHETER 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 22008270 ↗MalfunctionMay 13, 2025Fracture; Material Separation; Fracture; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST A CATHETER PLACEMENT, THE DRAINAGE CATHETER 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 22008260 ↗MalfunctionMay 13, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST A CATHETER PLACEMENT, THE DRAINAGE CATHETER 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 22008259 ↗MalfunctionApr 13, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102594 ↗MalfunctionApr 13, 2024Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102593 ↗MalfunctionAug 17, 2023Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH THE DRAINAGE BAG WAS ALLEGEDLY 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 17562360 ↗MalfunctionAug 17, 2023Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH THE DRAINAGE BAG WAS ALLEGEDLY FOUND TO BE FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17562354 ↗MalfunctionJan 10, 2022Fracture; Suction Problem; Fracture; Suction Problem
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE FOR A SUCTION TREATMENT OF THE LIVER CYST, THE DEVICE WAS ALLEGEDLY CRACKED AND COULD NOT BE SUCKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13204055 ↗MalfunctionOct 29, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL NOD8J CHRONIC CATHETER ALLEGEDLY EXPERIENCED CRACK ON THE HUB OF THE CATHETER AND LEAKAGE. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCE. THE TWO REPORTED MALFUNCTION INVOLVED TWO PATIENT WITH NO CONSEQUENCES. THE TWO MALE PATIENTS WERE REPORTED TO BE BETWEEN 50 TO 62 YEARS OLD AND WEIGHED BETWEEN 57 TO 60 KGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10759299 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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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