Navarre NBD8Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741036866), received between Jun 1, 2017 and Dec 3, 2025 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Break” (49 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE OF PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTCD) FOR OBSTRUCTIVE JAUNDICE CAUSED BY A PANCREATIC MASS. ON THE THIRD POSTOPERATIVE DAY, THE DRAINAGE TUBE CONNECTOR WAS RUPTURED, RESULTING IN BILE LEAKAGE. DESPITE BANDAGING, THE LEAKAGE PERSISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701535 ↗
• MalfunctionNov 24, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A DSA GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE BILIARY DRAINAGE CATHETER. AFTER 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 23630260 ↗
• MalfunctionOct 8, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE BILIARY 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 23242445 ↗
• MalfunctionOct 8, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE BILIARY 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 23242443 ↗
• MalfunctionOct 8, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE BILIARY 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 23242442 ↗
• MalfunctionMar 16, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST DRAINAGE CATHETER PLACEMENT FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE, THE CATHETER HUB ALLEGEDLY CRACKED WHICH RESULTED IN LEAKAGE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13788967 ↗
• MalfunctionMay 7, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STYLET BROKE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS USING THE STYLET AS A SUPPORT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493110 ↗
• MalfunctionMar 6, 2018Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION OF INSERTION OF THE PLASTIC STIFFENER, THE USER OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER TESTED THE PLASTIC STIFFENER BEFORE USAGE AND IT BROKE "AS GLASS TUBE" IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7318007 ↗
• MalfunctionFeb 7, 2018Break; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USING THE DEVICE, DURING PREPARATION OF THE DRAIN (INSERTION OF THE PLASTIC STIFFENER INTO THE DRAIN) IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER EXPERIENCED LOW ELASTICITY OF THE PLASTIC STIFFENER. HE TESTED IT AND THE PLASTIC STIFFENER BROKE ¿AS GLASS TUBE¿ IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. HE TRIED ANOTHER ONE FROM THE SAME LOT WITH THE SAME RESULT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE FIFTH OF FIVE DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7249162 ↗
• MalfunctionFeb 7, 2018Break; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USING THE DEVICE, DURING PREPARATION OF THE DRAIN (INSERTION OF THE PLASTIC STIFFENER INTO THE DRAIN) IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER EXPERIENCED LOW ELASTICITY OF THE PLASTIC STIFFENER. HE TESTED IT AND THE PLASTIC STIFFENER BROKE ¿AS GLASS TUBE¿ IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. HE TRIED ANOTHER ONE FROM THE SAME LOT WITH THE SAME RESULT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE SECOND OF FIVE DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249055 ↗
• MalfunctionFeb 7, 2018Break

  IT WAS REPORTED THAT PRIOR TO USING THE DEVICE, DURING PREPARATION OF THE DRAIN (INSERTION OF THE PLASTIC STIFFENER INTO THE DRAIN) IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER EXPERIENCED LOW ELASTICITY OF THE PLASTIC STIFFENER. HE TESTED IT AND THE PLASTIC STIFFENER BROKE ¿AS GLASS TUBE¿ IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. HE TRIED ANOTHER ONE FROM THE SAME LOT WITH THE SAME RESULT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE FOURTH OF FIVE DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249054 ↗
• MalfunctionFeb 7, 2018Break; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USING THE DEVICE, DURING PREPARATION OF THE DRAIN (INSERTION OF THE PLASTIC STIFFENER INTO THE DRAIN) IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER EXPERIENCED LOW ELASTICITY OF THE PLASTIC STIFFENER. HE TESTED IT AND THE PLASTIC STIFFENER BROKE ¿AS GLASS TUBE¿ IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. HE TRIED ANOTHER ONE FROM THE SAME LOT WITH THE SAME RESULT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE THIRD OF FIVE DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7249052 ↗
• MalfunctionFeb 7, 2018Break; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USING THE DEVICE, DURING PREPARATION OF THE DRAIN (INSERTION OF THE PLASTIC STIFFENER INTO THE DRAIN) IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER EXPERIENCED LOW ELASTICITY OF THE PLASTIC STIFFENER. HE TESTED IT AND THE PLASTIC STIFFENER BROKE ¿AS GLASS TUBE¿ IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. HE TRIED ANOTHER ONE FROM THE SAME LOT WITH THE SAME RESULT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE FIRST OF FIVE DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7249050 ↗
• MalfunctionFeb 6, 2018Break

  IT WAS REPORTED THAT DURING PREPARATION OF INSERTION OF THE PLASTIC STIFFENER, IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER TESTED IT AND THE PLASTIC STIFFENER BROKE "AS GLASS TUBE" IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE SECOND OF TWO DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7246067 ↗
• MalfunctionFeb 6, 2018Break

  IT WAS REPORTED THAT DURING PREPARATION OF INSERTION OF THE PLASTIC STIFFENER, IT WAS OBSERVED THAT THE PLASTIC STIFFENER WAS EXTREMELY FRAGILE. THE USER TESTED IT AND THE PLASTIC STIFFENER BROKE "AS GLASS TUBE" IN HIS HANDS WITHOUT THE USE OF GREAT FORCE. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES THE FIRST OF TWO DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7246008 ↗
• MalfunctionJan 16, 2018Break

  IT WAS REPORTED THAT DURING PTC PROCEDURE THE PLASTIC DILATOR BROKE FROM THE TIP WHEN ATTEMPTING TO REMOVE IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7198480 ↗
• MalfunctionJan 11, 2018Break

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS DOING THE PTC PROCEDURE, THE PLASTIC STYLET BROKE. IT WAS STATED HE COMPLETED THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7182136 ↗
• MalfunctionDec 7, 2017Break

  IT WAS REPORTED THAT WHILE PREPARING FOR THE PROCEDURE, THE NURSE REPORTEDLY THREADED THE PLASTIC STYLET OVER THE CATHETER. DURING THE PROCEDURE THE PLASTIC STYLET ALLEGEDLY BROKE. PROCEDURE WAS COMPLETED USING THE METALLIC STYLET INSTEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094643 ↗
• MalfunctionNov 22, 2017Break

  WHILE PREPARING FOR THE PTC PROCEDURE, IT WAS REPORTED THAT THE NURSE THREADED THE PLASTIC STYLET OVER THE CATHETER AND WHILE DOING IT, THE PLASTIC STYLET ALLEGEDLY BROKE APPROXIMATELY 5 CM FROM THE HUB . THE PROCEDURE WAS REPORTEDLY COMPLETED USING THE METALLIC STYLET INSTEAD. NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7053884 ↗
• MalfunctionNov 2, 2017Break

  IT WAS REPORTED THAT DURING THE PREPARATION OF PTC PROCEDURE, THE PHYSICIAN WAS THREADING THE PLASTIC STYLET OVER THE CATHETER AND BEFORE HE COULD FULLY THREAD IT IN, THE PLASTIC STYLET HUB ALLEGEDLY BROKE. A NEW CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998032 ↗
• MalfunctionOct 24, 2017Break

  IT WAS REPORTED THAT AFTER CHECKING WITH THE NURSE, THE STAFF WAS PREPARING FOR A PTC PROCEDURE AND ATTEMPTED TO THREAD THE PLASTIC STYLET INTO THE CATHETER. IT WAS STATED BEFORE SHE COULD THREAD THE PLASTIC STYLET IN, THE HUB OF THE STYLET BROKE FROM THE MAIN BODY OF THE PLASTIC STYLET. ANOTHER NEW SET HAD TO BE OPENED TO COMPLETE THE PROCEDURE. ORIGINAL DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6974786 ↗
• MalfunctionSep 22, 2017Break

  THE PLASTIC FIXATOR OF ALL THE UNITS FROM THE INDICATED BATCH NUMBER BREAKS EASILY. THE ISSUE WAS FOUND AT THE DISTRIBUTOR FACILITY. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES DEVICE #10.

  Patient problems: No Patient Involvement

  MAUDE report 6886463 ↗
• MalfunctionSep 22, 2017Break

  THE PLASTIC FIXATOR OF ALL THE UNITS FROM THE INDICATED BATCH NUMBER BREAKS EASILY. THE ISSUE WAS FOUND AT THE DISTRIBUTOR FACILITY. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES DEVICE #9.

  Patient problems: No Patient Involvement

  MAUDE report 6886458 ↗
• MalfunctionSep 22, 2017Break

  THE PLASTIC FIXATOR OF ALL THE UNITS FROM THE INDICATED BATCH NUMBER BREAKS EASILY. THE ISSUE WAS FOUND AT THE DISTRIBUTOR FACILITY. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES DEVICE #7.

  Patient problems: No Patient Involvement

  MAUDE report 6886379 ↗
• MalfunctionSep 22, 2017Break

  THE PLASTIC FIXATOR OF ALL THE UNITS FROM THE INDICATED BATCH NUMBER BREAKS EASILY. THE ISSUE WAS FOUND AT THE DISTRIBUTOR FACILITY. NO PATIENT INVOLVEMENT. THIS FILE ADDRESSES DEVICE #5.

  Patient problems: No Patient Involvement

  MAUDE report 6886376 ↗