Navarre Opti-Drain NOD12LPTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Opti-Drain Multi-Use Drainage Catheter, Locking Pigtail, 12 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 Opti-Drain is a locking pigtail drainage catheter used to drain fluid from places such as the kidney, liver or cysts. There are 67 adverse event reports, mostly describing the catheter breaking or cracking during use, with pieces separating, leaking fluid, a blocked inner channel, and a locking thread that would not hold. The reports mention no deaths and 4 injuries. No recalls name this device, and reports in the past 12 months fell from 30 to 13.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741037061), received between Nov 19, 2018 and May 18, 2026 — classified as 4 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Fracture” (24 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
- Fracture24
- Break22
- Material Separation20
- Fluid/Blood Leak16
- Nonstandard Device6
- Material Integrity Problem5
- Deformation Due to Compressive Stress4
- Device Damaged Prior to Use4
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient4
- Pneumothorax3
- Extravasation1
- Wound Infection1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Nonstandard Device
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED CYST PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE OPTI DRAIN CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE LENGTH OF THE TROCAR NEEDLE WAS SHORTER THAN THE CATHETER. THE DRAINAGE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197364 ↗MalfunctionMay 18, 2026Nonstandard Device
ON (B)(6) 2026, THE PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN CATHETER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY 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 25197321 ↗MalfunctionMar 23, 2026Failure to Advance; Blocked Connection; Material Integrity Problem
ON (B)(6) 2026, THE PATIENT UNDERWENT AN ULTRASOUND-GUIDED CYST PERCUTANEOUS DRAINAGE PROCEDURE USING A NAVARRE OPTI DRAIN CATHETER. DURING THE PROCEDURE, THE CLINICIAN INSPECTED THE PACKAGE AND PRODUCT PRIOR TO USE AND CONFIRMED THAT BOTH WERE INTACT. HOWEVER, DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE MIDDLE CHANNEL OF THE DRAINAGE DEVICE WAS BLOCKED, WHICH PREVENTED SMOOTH INSERTION OF THE GUIDE WIRE. IT WAS FURTHER REPORTED THAT DAMAGE WAS NOTED TO THE TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659471 ↗MalfunctionFeb 9, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE, THE SURE-LOK TM THREAD HAD DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288725 ↗MalfunctionFeb 9, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE, THE SURE-LOK TM THREAD HAD DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288724 ↗MalfunctionFeb 9, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING A NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE, THE SURE-LOK TM THREAD HAD DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288710 ↗MalfunctionJan 20, 2026Nonstandard Device
ON (B)(6) 2025, A PATIENT UNDERWENT FOR AN ULTRASOUND GUIDED CYST PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. PRIOR TO THE PROCEDURE, THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY SHORTER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24113203 ↗MalfunctionJan 20, 2026Nonstandard Device
ON (B)(6) 2025, A PATIENT PREPPED FOR AN ULTRASOUND-GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY SHORTER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112769 ↗MalfunctionJan 20, 2026Nonstandard Device
ON (B)(6) 2025, A PATIENT PREPPED FOR AN ULTRASOUND-GUIDED CYST DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY SHORTER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112493 ↗MalfunctionJan 9, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. POST THE PROCEDURE, AFTER RETURNING TO THE WARD POSTOPERATIVELY, LEAKAGE OCCURRED AT THE CONNECTION POINT OF THE CATHETER TIP. THE LEAKING AT THE CONNECTOR WAS CAUSED BY A CRACKED DRAIN TUBING. THE CONNECTING TUBE WAS IMMEDIATELY REMOVED, AND A RUBBER CONNECTOR WAS REAPPLIED TO SEAL THE TEAR AT THE CATHETER TIP. THE ISSUE WAS RESOLVED BY REPLACING THE LEAKING RUBBER CONNECTOR. THERE WERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018820 ↗MalfunctionDec 5, 2025Difficult to Insert; Nonstandard Device; Failure to Advance; Difficult to Insert; Nonstandard Device; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY TOO SHORT, MAKING IMPOSSIBLE TO INSERT THE GUIDEWIRE SMOOTHLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725800 ↗MalfunctionDec 3, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN CATHETER. POST THE PROCEDURE, A BREAK OCCURRED IN THE BODY OF THE DRAINAGE CATHETER. THE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704150 ↗InjuryNov 18, 2025Fluid/Blood Leak; Fracture; Material Separation; Air/Gas in Device; Fluid/Blood Leak; Fracture; Material Separation; Air/Gas in Device
ON (B)(6) 2025, A PATIENT DIAGNOSED WITH THYMOMA UNDERWENT THORACOSCOPIC EXTENDED THYMECTOMY WITH RIGHT LOWER LOBE WEDGE RESECTION USING THE NAVARRE OPTI DRAIN. POST PROCEDURE, A TUBE WAS RETAINED FOR PLEURAL FLUID AND AIR DRAINAGE. LATER A MINOR LEAKAGE WAS OBSERVED AT THE CHEST TUBE CONNECTOR, AND EXAMINATION REVEALED A FRACTURE IN THE RIGID SECTION OF THE CONNECTOR. THE PATIENT REPORTED MILD CHEST TIGHTNESS WITH OXYGEN SATURATION AT 95%, AND AUSCULTATION SHOWED SLIGHTLY DIMINISHED BREATH SOUNDS ON THE RIGHT SIDE. THE DRAINAGE TUBE CONNECTOR WAS REPLACED, AND A CHEST X-RAY REVEALED A SMALL PNEUMOTHORAX. THE PATIENT WAS INSTRUCTED TO COUGH TO EXPEL TRAPPED AIR, AFTER WHICH CHEST TIGHTNESS RESOLVED, OXYGEN SATURATION IMPROVED TO 99%, AND BREATH SOUNDS NORMALIZED. THE PATIENT REMAINED UNDER OBSERVATION AND WAS LATER DISCHARGED WITHOUT FURTHER COMPLICATIONS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Pneumothorax
MAUDE report 23580834 ↗MalfunctionOct 30, 2025Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI-DRAIN DRAINAGE CATHETER. IT WAS REPORTED THAT POST CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FOUND FRACTURED. REPORTEDLY, DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FOUND LEAKING POINT IS LOCATED AT THE JUNCTION BETWEEN THE CATHETER BODY AND THE WHITE CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424245 ↗MalfunctionOct 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN. SOMETIMES POST A PROCEDURE ON (B)(6) 2025, A LEAK WAS IDENTIFIED AT THE CONNECTION POINT OF A SINGLE-USE 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 23307653 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI-DRAIN. POST A PORT PLACEMENT PROCEDURE, IT WAS FOUND THAT THE SURE-LOKTM THREAD WAS ALLEGEDLY FOUND DIGRESSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120569 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. POST THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119810 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. POST THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119809 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED PCN PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE OPTI DRAIN. POST THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119698 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI-DRAIN. POST A PORT PLACEMENT PROCEDURE, IT WAS FOUND THAT THE SURE-LOKTM THREAD WAS ALLEGEDLY FOUND DIGRESSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119697 ↗MalfunctionSep 23, 2025Break; Material Separation; Break; Material Separation
A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI-DRAIN. POST A PORT PLACEMENT PROCEDURE, IT WAS FOUND THAT THE SURE-LOKTM THREAD WAS ALLEGEDLY FOUND DIGRESSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119696 ↗MalfunctionSep 22, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. AFTER THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23107969 ↗MalfunctionSep 22, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. AFTER THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23107715 ↗MalfunctionSep 22, 2025Break; Material Separation; Break; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. AFTER THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23107714 ↗MalfunctionJul 23, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE DRAINAGE CATHETER CONNECTOR WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574411 ↗
Other CATHETER, IRRIGATION devices
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- 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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