Navarre NBD12Recalls & reported problems
Bard Access Systems, Inc. · Navarre Percutaneous Biliary Drainage Catheter with Nitinol, 12F Locking Pigtail · Class 2 · Implant
All models of Navarre (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741036859), received between Nov 15, 2017 and Aug 3, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Kinked1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AS THE NURSE WAS INSERTING THE STYLET (BEFORE INSERTING THE CATHETER OVER THE GUIDEWIRE), IT WAS OBSERVED THAT THERE WAS A TEAR AT THE TIP OF THE CATHETER. THE NURSE HAD BEEN PREPPING THE PATIENT FOR A BILIARY DRAIN PROCEDURE. A NEW TUBE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7747139 ↗MalfunctionNov 15, 2017Kinked
IT WAS REPORTED THAT WHILE PREPARING FOR THE PTC PROCEDURE, THE NURSE THREADED THE PLASTIC STYLET OVER THE CATHETER. THEY REPORTEDLY FOUND THAT THE CATHETER HAD KINKED WHILE STRAIGHTENING. IT WAS STATED THAT THE DECISION WAS MADE NOT TO USE THE CATHETER AND A NEW SET WAS OPENED TO COMPLETE THE PROCEDURE. DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7033255 ↗
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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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