Navarre NNU10LPTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Universal Drainage Catheter with Nitinol, Locking Pigtail, 10 fr x 30 cm · Class 1
All models of Navarre (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Navarre drainage catheter has 130 adverse event reports on record, with no deaths and 3 injuries. The reports mostly describe connectors or tubing cracking, fracturing, or breaking, and some mention fluid leaking at the connection. Most say no clinical signs or patient impact were reported. There are no recalls naming this device.
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
- 127
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00801741036903), received between Jul 11, 2018 and Aug 27, 2026 — classified as 3 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Fracture” (82 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
- Fracture82
- Material Separation29
- Break22
- Defective Component15
- Fluid/Blood Leak15
- Crack4
- Deformation Due to Compressive Stress2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- No Consequences Or Impact To Patient8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Device Embedded In Tissue or Plaque1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Fracture
On (b)(6), 2026, a patient underwent an ultrasound guided hydrothorax percutaneous drainage procedure using a Navarre Universal Drainage Catheter. During the procedure, the drainage catheter connector fractured. The procedure was completed using another device. There was no reported patient injury.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50485304 ↗MalfunctionJun 19, 2026Fracture
A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. ON (B)(6) 2026, AFTER THE PROCEDURE, IT WAS REPORTED THAT 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 25557050 ↗MalfunctionJun 19, 2026Fracture
A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. ON (B)(6) 2026, AFTER THE PROCEDURE, IT WAS REPORTED THAT 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 25557047 ↗MalfunctionJun 16, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR AN ULTRASOUND GUIDED ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PREPARATION, THE SURE LOKTM THREAD WAS ALLEGEDLY DIGRESSIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25517448 ↗MalfunctionJun 8, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT A PLACEMENT PROCEDURE FOR A DRAINAGE SYSTEM FOR MANAGEMENT OF A LUMBAR PSOAS ABSCESS. ON THE THIRD DAY FOLLOWING PLACEMENT, THE CONNECTING TUBE RUPTURED, RESULTING IN LEAKAGE AND SPILLAGE OF DRAINAGE FLUID. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425379 ↗MalfunctionMay 21, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT SURELOKTM 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 25239805 ↗MalfunctionMay 21, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT SURELOKTM 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 25239802 ↗MalfunctionMay 7, 2026Break; Material Separation
A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PROCEDURE FOR ASCITES USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PROCEDURE ON (B)(6) 2026, IT WAS IDENTIFIED THAT THE SURE LOK THREAD WAS BROKEN, WITH THE DAMAGE LIMITED TO THE SURE LOK THREAD COMPONENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE THREAD, AND NO VISIBLE GLUE WAS OBSERVED AT THE END OF THE DISENGAGED THREAD. AS A RESULT OF THIS ISSUE, THE AFFECTED DRAINAGE CATHETER WAS REPLACED WITH A NEW DRAINAGE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25109189 ↗MalfunctionMay 5, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT DURING 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 25089544 ↗MalfunctionMay 5, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT DURING 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 25089521 ↗MalfunctionMar 9, 2026Fluid/Blood Leak; Fracture
A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. APPROXIMATELY SEVEN DAYS POST THE PLACEMENT, THE DRAINAGE CATHETER WAS ALLEGEDLY FRACTURED AND CAUSED IT TO LEAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543479 ↗MalfunctionFeb 23, 2026Fracture
A PATIENT UNDERWENT A CT GUIDED PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. ON (B)(6) 2026, AFTER THE PROCEDURE, THE DRAINAGE CATHETER CONNECTOR FRACTURED. 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 24411197 ↗MalfunctionFeb 18, 2026Break; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT ASCITES PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE. POST PROCEDURE THE SURE LOK TM THREAD ALLEGEDLY HAD DIGRESSION. FURTHERMORE, BREAK WAS ALSO REPORTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374671 ↗MalfunctionFeb 9, 2026Fracture
A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE UNIVERSAL DRAINAGE CATHETER. POST PLACEMENT PROCEDURE, ON (B)(6) 2026, IT WAS REPORTED THAT THE CONNECTOR OF THE 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 24290352 ↗MalfunctionDec 19, 2025Fracture; Material Separation; Fracture; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT A NAVARRE UNIVERSAL DRAINAGE CATHETER PLACEMENT. IT WAS REPORTED THAT POST A CATHETER PLACEMENT, THE WHITE CONNECTING HUB OF THE DRAIN WAS ALLEGEDLY FOUND BROKEN. FURTHER, IT WAS REPORTED THAT THE CATHETER WAS COMPLETELY BROKEN. THE DRAIN HAS BEEN REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847251 ↗MalfunctionDec 10, 2025Fracture; Material Separation; Fracture; Material Separation
ON (B)(6) 2025, A PATIENT UNDERWENT NAVARRE UNIVERSAL DRAINAGE CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE THE LOCKING HUB WAS ALLEGEDLY FOUND CRACKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766194 ↗MalfunctionDec 8, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE CATHETER. POST-PROCEDURE, ON (B)(6) 2025, IT WAS NOTED THAT THERE WAS A TEAR IN THE WHITE CONNECTING HUB, CAUSING FLUID LEAKAGE THROUGH THE TEAR. THE TEAR OCCURRED AFTER THE CATHETER WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739389 ↗MalfunctionDec 4, 2025Fracture; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A DIGITAL SUBTRACTION ANGIOGRAPHY GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. POST THE PROCEDURE, 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 23714213 ↗MalfunctionNov 19, 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 THE PROCEDURE, 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 23591898 ↗MalfunctionNov 6, 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 FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIO-DRAINAGE. AFTER THE PROCEDURE, THE SURE-LOKTM THREAD WAS ALLEGEDLY FOUND DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484406 ↗MalfunctionNov 6, 2025Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PROCEDURE FOR ABSCESS USING THE NAVARRE UNIVERSAL DRAIN. DURING THE PROCEDURE, WHICH IS PERFORMED UNDER ULTRASOUND GUIDANCE, A PRODUCT ISSUE WAS IDENTIFIED. POST-PROCEDURE, IT WAS OBSERVED 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 23483950 ↗MalfunctionOct 28, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
A DEFECTIVE NAVARRE 10FR CATHETER WAS USED DURING A NEPHROSTOMY PROCEDURE. THE CATHETER EXHIBITED A CRACK AT THE WHITE JUNCTION BEFORE THE DRAINAGE CONNECTION, RESULTING IN A FAILURE TO TRANSCATHERIZE USING BOTH AMPLATZ AND HYDROPHILIC GUIDES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400191 ↗MalfunctionAug 26, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOSCOPIC GUIDED ASCITES DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. PRIOR TO THE PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892294 ↗MalfunctionAug 13, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOSCOPIC GUIDED CHEST ASCITES PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAIN. IT WAS REPORTED THAT DURING PREPARATION; THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792679 ↗MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6), THE DEVICE WAS IMPLANTED ON 71-YEAR-OLD PATIENT. ON (B)(6) 2025, POST A CHRONIC CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY FOUND LEAKING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676501 ↗
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- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
- 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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