Liverty 306466Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903064663), received between Mar 15, 2023 and Aug 31, 2026 — classified as 3 injuries, 7 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 31, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517988 ↗
• MalfunctionFeb 13, 2026Material Puncture/Hole

  ON (B)(6) 2026. A PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A LIVERTY SET. THE CUSTOMER STATED THAT THE DEVICE HAD A HOLE OR DISTAL DEFECT, UPON FLUSHING BEFORE USE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330710 ↗
• MalfunctionDec 22, 2025Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE USING THE LIVERTY TIPS ACCESS SET. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE FOREIGN MATTER WAS FOUND INSIDE THE PUNCTURE KIT PACKAGING UPON OPENING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861710 ↗
• MalfunctionNov 24, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING TRANS JUGULAR LIVER ACCESS SET. DURING THE PROCEDURE. THE ADJUSTABLE TIP OF THE DEVICE FRACTURED DURING CANNULA ROTATION PRIOR TO TIPS PUNCTURE. THIS REQUIRED DELICATELY REMOVING THE FRACTURED CANNULA AND USING A NEW KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628887 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE USING LIVERTY TIPS ACCESS SET. IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE ALLEGEDLY DID NOT ASPIRATE. ADDITIONALLY, THE CANNULA ALLEGEDLY SHREDDED THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937911 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT THREE WEEKS AND THREE DAYS POST AN INDEX PROCEDURE USING A LIVERTY TIPS ACCESS SET THROUGH RIGHT JUGULAR VEIN, THE SUBJECT ALLEGEDLY HAD AN ADVERSE EVENT OF HYPOKALEMIA AND HYPERBILIRUBINEMIA. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT RELATIONSHIP WAS POSSIBLY RELATED TO THE TIPS ACCESS SET AND TIPS STENT GRAFT AND CAUSALLY RELATED TO TIPS INDEX PROCEDURE. REPORTEDLY, THE SUBJECT WAS TREATED WITH POTASSIUM CHLORIDE AND RECOVERING. THE CURRENT STATUS OF THE SUBJECT WAS UNKNOWN.

  Patient problems: Hyperbilirubinemia

  MAUDE report 20721512 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT ONE DAY POST A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION VIA THE RIGHT INTERNAL JUGULAR VEIN, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF ACUTE INCREASED ABDOMINAL PAIN. IT WAS FURTHER REPORTED THAT THE SUBJECT DEVELOPED AN ADVERSE EVENT OF DIARRHEA, BUT THE SEVERITY OF ADVERSE EVENT WAS MILD. REPORTEDLY, THE OUTCOME OF THE ADVERSE EVENTS WERE RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 18606306 ↗
• MalfunctionJul 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE, THE CATHETER OF THE KIT ALLEGEDLY HAD BROKEN AND DISLODGED INTO PATIENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAD TO SNARE THE PIECE OF THE CATHETER THAT BROKE LOOSE OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257123 ↗
• InjuryMar 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE, THE CATHETER ALLEGEDLY SHEARED WHEN TRIED TO PUSH THE NEEDLE. IT WAS FURTHER REPORTED THAT THERE WAS ABOUT AN INCH OF THE CATHETER LEFT IN THE PATIENT. FURTHER IT TOOK THREE HOURS TO REMOVE THE SEGMENT FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16654467 ↗
• MalfunctionMar 15, 2023Break; Fracture; Difficult to Advance; Break; Fracture; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE, THE DEVICE ALLEGEDLY HAD DIFFICULTY IN TRACKING AND SEEING THE NEEDLE THROUGH INTRACARDIAC ECHOCARDIOGRAPHY. IT WAS FURTHER REPORTED THAT THE FLEX POINT OF THE NEEDLE ALLEGEDLY BROKE AND LOST ALL PUSH AS WELL AS PUNCTURE ABILITY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543754 ↗