Navarre Opti-Drain NOD10PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741037047), received between Jul 11, 2018 and Oct 27, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH THE DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019876 ↗
• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH THE DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019866 ↗
• MalfunctionOct 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH THE DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019810 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929086 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929085 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST AN ULTRASOUND GUIDED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE CATHETER PLACEMENT, THE DRAINAGE CATHETER CONNECTOR THAT CONNECTED WITH DRAINAGE BAG WAS ALLEGEDLY FRACTURED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929084 ↗
• MalfunctionNov 25, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE END OF THE CONNECTOR WAS ALLEGEDLY NOTED TO BE BROKEN OFF. IT WAS FURTHER REPORTED THAT THE DEVICE LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873624 ↗
• MalfunctionNov 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT POST CHRONIC CATHETER PLACEMENT, THE END OF THE CONNECTOR WAS ALLEGEDLY BROKEN OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873497 ↗
• MalfunctionNov 25, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE END OF THE CONNECTOR WAS ALLEGEDLY NOTED TO BE BROKEN OFF. IT WAS FURTHER REPORTED THAT THE DEVICE LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873361 ↗
• InjuryJul 11, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT A PIGTAIL DRAIN WAS PLACED IN A PATIENT WITH RESPIRATORY INSUFFICIENCY AND PRONOUNCED PLEURAL EFFUSION WITHOUT COMPLICATIONS. THE NEXT DAY, A CXR REVEALED AN IPSILATERAL APICAL PNEUMOTHORAX. A DEFECTIVE CONE ON THE PIGTAIL WAS DISCOVERED AND THE DEVICE WAS REMOVED AND 2.5 LITERS OF SEROUS PLEURAL FLUID WAS EMPTIED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED 2-3 DAYS AFTER THE PLACEMENT PROCEDURE, BUT ALLEGEDLY NOT IN CONNECTION WITH THE COMPLAINT BUT DUE TO MALIGNANT PLEURAL EFFUSION.

  Patient problems: Death; Pneumothorax

  MAUDE report 7677651 ↗