Navarre NNU12LPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00801741036934), received between Apr 11, 2017 and Mar 18, 2026 — classified as 1 injury, 47 malfunctions.

The most frequently reported specific device problem is “Defective Component” (19 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDRONEPHROSIS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. POST THE PROCEDURE, THE SURE LOKTM THREAD HAD DIGRESSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625200 ↗
• MalfunctionDec 11, 2025Obstruction of Flow; Deformation Due to Compressive Stress; Obstruction of Flow; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAIN. THE PIGTAIL PEN WAS ALLEGEDLY DISCOUNTED, AND DRAINAGE CANNOT BE CONTINUED. FURTHER IT WAS REPORTED THAT THE CATHETER BECAME KINKED, PREVENTING DRAINAGE FROM THE INTERNAL LUMEN. A CT SCAN SHOWED THAT THERE WAS STILL FLUID IN THE THORACIC CAVITY THAT COULD NOT BE DRAINED. REPORTEDLY, THE DRAINAGE WAS OBSTRUCTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778269 ↗
• MalfunctionNov 17, 2025Air/Gas in Device; Air/Gas in Device

  A PATIENT UNDERWENT A NAVARRE UNIVERSAL DRAINAGE CATHETER PLACEMENT PROCEDURE. DURING THE PROCEDURE THE DEVICE WAS ALLEGEDLY HAD AIR IN DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567413 ↗
• MalfunctionNov 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2025, DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHIC DRAINAGE PROCEDURE PERFORMED UNDER ULTRASOUND GUIDANCE, A PRODUCT ISSUE WAS ENCOUNTERED. IT WAS REPORTED THAT A KINK WAS OBSERVED AT THE SIDE PORT OF THE DRAINAGE TUBING DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529677 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fracture; Material Separation; Fluid/Blood Leak; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER FOR ASCITES UNDER ULTRASOUND GUIDANCE. DURING THE PROCEDURE, THE DRAINAGE CATHETER CONNECTOR FRACTURED CAUSING A SIGNIFICANT AMOUNT OF ASCITES FLUID TO LEAK ONTO THE PATIENT'S BEDDING AND CLOTHING DURING THE TUBE'S RETENTION PERIOD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484236 ↗
• MalfunctionNov 3, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PLASTIC TIP OF THE DRAIN ALLEGEDLY EXTENDS BEYOND THE METAL TIP OF THE MANDREL AFTER THE DRAIN IS ASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447535 ↗
• MalfunctionNov 3, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE USING THE NAVARRE UNIVERSAL DRAINAGE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE PLASTIC TIP OF THE DRAIN ALLEGEDLY EXTENDS BEYOND THE METAL TIP OF THE MANDREL AFTER THE DRAIN IS ASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447505 ↗
• InjurySep 12, 2025Fracture; Material Separation; Fracture; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT IMPLANTATION OF NAVARRE UNIVERSAL DRAINAGE CATHETER PLACEMENT. IT WAS REPORTED THAT ON (B)(6) 2025, POST CATHETER PLACEMENT, THE END OF THE DRAIN TUBING ALLEGEDLY FOUND RUPTURED CAUSING THE CLOSED DRAIN. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED MILD CHEST TIGHTNESS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Pneumothorax

  MAUDE report 23035125 ↗
• MalfunctionJul 10, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE USING NAVARRE UNIVERSAL DRAINAGE CATHETER. DURING THE PREPARATION PROCEDURE, THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY SHORTER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466855 ↗
• MalfunctionApr 24, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF A HYDROTHORAX DRAINAGE CATHETER PLACEMENT, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY SHORTER THAN CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899126 ↗
• MalfunctionApr 8, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A PREPARATION OF AN ULTRASOUND GUIDED HYDROTHORAX DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. IT WAS FURTHER REPORTED THAT TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793873 ↗
• MalfunctionApr 7, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ULTRASOUND GUIDED ABSCESS PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. IT WAS FURTHER REPORTED THAT TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783821 ↗
• MalfunctionApr 7, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ULTRASOUND GUIDED ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. IT WAS FURTHER REPORTED THAT TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783819 ↗
• MalfunctionApr 7, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A PREPARATION OF AN ULTRASOUND GUIDED HYDROTHORAX PERCUTANEOUS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER. IT WAS FURTHER REPORTED THAT TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21782910 ↗
• MalfunctionApr 7, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY LONGER THAN CATHETER.IT WAS FURTHER REPORTED THAT TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21782859 ↗
• MalfunctionApr 5, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE ALLEGEDLY WAS SHORTER THAN CATHETER AND TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21781196 ↗
• MalfunctionApr 5, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE ALLEGEDLY WAS SHORTER THAN CATHETER AND TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21781182 ↗
• MalfunctionApr 5, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND GUIDED ABSCESS PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE ALLEGEDLY WAS SHORTER THAN CATHETER AND TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21781146 ↗
• MalfunctionApr 5, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PREPARATION OF AN ULTRASOUND GUIDED PERCUTANEOUS DRAINAGE PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE ALLEGEDLY WAS SHORTER THAN CATHETER AND TIP OF THE NEEDLE WAS NOT EXPOSED. THE PROCEDURE WAS COMPLETED BY REPLACING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21781143 ↗
• MalfunctionJul 15, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO AN COMPUTED TOMOGRAPHY-GUIDED PERCUTANEOUS ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF THE TROCAR NEEDLE WAS ALLEGEDLY FOUND TO BE LONGER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738371 ↗
• MalfunctionApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE WHITE COUPLING TIP OF THE CATHETER HAD ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094445 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE WHITE COUPLING TIP OF THE CATHETER HAD ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048675 ↗
• MalfunctionAug 23, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY FOUND TO BE LONGER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600911 ↗
• MalfunctionAug 23, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND-GUIDED ABSCESS DRAINAGE CATHETER PLACEMENT PROCEDURE, THE LENGTH OF TROCAR NEEDLE WAS ALLEGEDLY FOUND TO BE LONGER THAN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600908 ↗
• MalfunctionApr 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST DRAINAGE CATHETER PLACEMENT PROCEDURE, FRACTURE WAS ALLEGEDLY FOUND AT THE EXTERNAL CONNECTING HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723575 ↗