Navarre NNU8LP15Recalls & reported problems
Bard Access Systems, Inc. · Navarre Universal Drainage Catheter with Nitinol, Locking Pigtail, 8 Fr x 15 cm · Class 1
All models of Navarre (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741036996), received between Jul 19, 2019 and Sep 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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
- Fluid/Blood Leak3
- Fracture2
- Crack1
Patient problems
- Extravasation2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. AFTER THE PROCEDURE, THE DRAINAGE CATHETER WAS ALLEGEDLY FRACTURED. ADDITIONALLY, LEAK WAS NOTED AT THE CONNECTOR. REPORTEDLY EXTRAVASATION WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation
MAUDE report 23141326 ↗InjurySep 23, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED ASCITES DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE DRAINAGE CATHETER. AFTER THE PROCEDURE, THE DRAINAGE CATHETER WAS ALLEGEDLY FRACTURED. ADDITIONALLY, LEAK WAS NOTED AT THE CONNECTOR. REPORTEDLY EXTRAVASATION WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation
MAUDE report 23121067 ↗MalfunctionJul 19, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL NNU8LP15. CHRONIC CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK AND A CRACK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8809401 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page