Navarre Opti-Drain NOD8PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741037108), received between Jan 15, 2020 and Jan 14, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

• MalfunctionJan 14, 2026Fracture

  AN INTERVENTIONAL RADIOLOGIST INSERTED A NAVARRE DRAINAGE CATHETER AND CONNECTED A 3 WAY ADAPTER TO THE CATHETER HUB TO ALLOW ATTACHMENT TO A DRAINAGE BAG. THE FOLLOWING DAY, THE CATHETER HUB BROKE. SIMILAR INCIDENTS OF HUB BREAKAGE HAVE OCCURRED 2¿3 TIMES PREVIOUSLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064958 ↗
• MalfunctionAug 29, 2025Defective Component; Defective Component

  A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE NAVARRE OPTI DRAIN. IT WAS REPORTED THAT DURING THE PROCEDURE, CATHETER WAS ALLEGEDLY FOUND TOO LONG. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920396 ↗
• MalfunctionAug 19, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT DURING PREPARATION OF A NAVARRE OPTI DRAIN PLACEMENT PROCEDURE, THE DRAINAGE CATHETERS WAS ALLEGEDLY FOUND DIFFERENT LENGTH IN THE SAME BATCH. IT WAS FURTHER REPORTED THAT THE DRAINAGE CATHETERS WERE ALLEGEDLY TOO SHORT CANNOT BE USED FOR PATIENT OPERATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838258 ↗
• MalfunctionAug 19, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT DURING PREPARATION OF A NAVARRE OPTI DRAIN PLACEMENT PROCEDURE, THE DRAINAGE CATHETERS WAS ALLEGEDLY FOUND DIFFERENT LENGTH IN THE SAME BATCH. IT WAS FURTHER REPORTED THAT THE DRAINAGE CATHETERS WERE ALLEGEDLY TOO SHORT CANNOT BE USED FOR PATIENT OPERATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838241 ↗
• MalfunctionAug 19, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE BY USING NAVARRE DRAINAGE CATHETER. IT WAS REPORTED THAT DURING PREPARATION OF A NAVARRE OPTI DRAIN PLACEMENT PROCEDURE, THE DRAINAGE CATHETERS WAS ALLEGEDLY FOUND DIFFERENT LENGTH IN THE SAME BATCH. IT WAS FURTHER REPORTED THAT THE DRAINAGE CATHETERS WERE ALLEGEDLY TOO SHORT CANNOT BE USED FOR PATIENT OPERATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838238 ↗
• MalfunctionOct 11, 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 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 17910557 ↗
• MalfunctionMar 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO DAYS POST DIALYSIS CATHETER IMPLANT, THE DEVICE ALLEGEDLY HAD LEAK. REPORTEDLY, THE CATHTER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520346 ↗
• MalfunctionJan 17, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT UNDER ULTRASOUND-GUIDED PERCUTANEOUS RIGHT RENAL PELVIS PUNCTURE AND DRAINAGE, THE DRAINAGE TUBE INTERFACE WAS ALLEGEDLY CRACKED AND THE DRAINAGE FLUID WAS ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266400 ↗
• MalfunctionJan 12, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, CATHETER WAS ALLEGEDLY CRACKED AND THE DRAINAGE FLUID WAS ALLEGEDLY LEAKED THROUGH THE CRACK. IT WAS FURTHER REPORTED THAT THE TEMPORARY TAPE WAS WRAPPED AROUND IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234626 ↗
• MalfunctionJan 15, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL NOD8PT CHRONIC CATHETER ALLEGEDLY HAD A FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WAS NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593275 ↗