TLAB Transjugular Liver Access Biopsy System TL-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00886333218516), received between Nov 13, 2020 and Aug 9, 2025 — classified as 2 deaths, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2025Defective Component; Defective Component

  REPORTER STATES "I DO HAVE A DEFECTIVE TLABS KIT WHERE THE PLASTIC SHEATH COVERED OVER THE TOP OF THE NEEDLE AND CONSEQUENTLY THE MD WAS CUT TRYING TO UNSHEATHE THE NEEDLE TIP." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Tears

  MAUDE report 22767517 ↗
• MalfunctionDec 28, 2023Unraveled Material; Unraveled Material

  THE PHYSICIAN WAS PERFORMING A TRANS JUGULAR BIOPSY OF THE LIVER. ON INSERTION OF THE PRODUCT IT DID NOT CUT THE SAMPLE AS REQUIRED AND ON EXAMINATION THE MID SECTION OF THE DEVICE WAS DAMAGED. THE COATING ON THE DEVICE WAS UNRAVELED AS WELL WITH A SHARP PROTRUDING METAL PIECE. AS THE PATIENT HAD A VERY HIGH INR WITH HIGH RISK OF BLEEDING THIS DEVICE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL WHICH PERFORMED 100% AND ADEQUATE SAMPLES WERE EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411949 ↗
• DeathNov 16, 2023Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  THE REPORTED DEVICE WOULD NOT ACQUIRE ANY TISSUE SAMPLES DURING A TRANSJUGULAR LIVER BIOPSY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE PROVIDER REPORTED THAT THE DISTAL PORTION OF THE BIOPSY NEEDLE WAS BENT/CURVED AND LOOKED UNUSUAL ALTHOUGH NOTHING ABNORMAL WAS ABSORBED UNDER FLUOROSCOPY DURING THE PROCEDURE. ANOTHER DEVICE WAS USED WITHOUT DIFFICULTY TO OBTAIN THE BIOPSY. FOLLOWING THE BIOPSY PROCEDURE, THE PATIENT HAD INTRAPERITONEAL HEMORRHAGE REQUIRING BLOOD TRANSFUSION AND HEPATIC ARTERY EMBOLIZATION. CT IMAGING DEMONSTRATED A LARGE VOLUME HEMOPERITONEUM AND PHYSICAL EXAM FINDINGS WERE CONCERNING FOR ABDOMINAL COMPARTMENT SYNDROME. THE PATIENT WAS IN THE PROCESS OF BEING TAKEN TO THE OR FOR ABDOMINAL DECOMPRESSION WHERE HE ARRESTED AND SUBSEQUENTLY EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 18148768 ↗
• DeathNov 9, 2023Failure to Obtain Sample; Material Twisted/Bent; Failure to Obtain Sample; Material Twisted/Bent

  THE REPORTED DEVICE WOULD NOT ACQUIRE ANY TISSUE SAMPLES DURING A TRANSJUGULAR LIVER BIOPSY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE PROVIDER REPORTED THAT THE DISTAL PORTION OF THE BIOPSY NEEDLE WAS BENT/CURVED AND LOOKED UNUSUAL ALTHOUGH NOTHING ABNORMAL WAS OBSERVED UNDER FLUOROSCOPY DURING THE PROCEDURE. ANOTHER DEVICE WAS USED WITHOUT DIFFICULTY TO OBTAIN THE BIOPSY. FOLLOWING THE BIOPSY PROCEDURE, THE PATIENT HAD INTRAPERITONEAL HEMORRHAGE REQUIRING BLOOD TRANSFUSIONS AND HEPATIC ARTERY EMBOLIZATION. CT IMAGING DEMONSTRATED A LARGE VOLUME HEMOPERITONEUM, AND PHYSICAL EXAM FINDINGS WERE CONCERNING FOR ABDOMINAL COMPARTMENT SYNDROME. THE PATIENT WAS IN THE PROCESS OF BEING TAKEN TO THE OPERATING ROOM FOR ABDOMINAL DECOMPRESSION WHEN HE ARRESTED AND SUBSEQUENTLY EXPIRED.

  Patient problems: Exsanguination; Low Blood Pressure/ Hypotension

  MAUDE report 18103768 ↗
• MalfunctionOct 15, 2021Therapeutic or Diagnostic Output Failure

  SYSTEM MALFUNCTIONING, DUE TO THE INCORRECT EXPOSURE OF THE TRU-CUT NEEDLE NOTCH. SEE ENCLOSED VIDEO. THE PROCEDURE HAS BEEN COMPLETED, BY DISCARDING THE DEVICE AND USING ANOTHER ONE OF THE SAME CODE/BATCH #. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12643746 ↗
• MalfunctionJul 8, 2021Break

  TIP OF THE PRODUCT BROKE OFF IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12139703 ↗
• MalfunctionMar 10, 2021Defective Component

  LOT# 1451428 ON FEB 9TH THAT THE SHEATH AROUND THE ACTUAL BIOPSY NEEDLE DETACHED FROM ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457214 ↗
• MalfunctionJan 25, 2021Break; Entrapment of Device; Migration

  RADIO-OPAQUE BAND ON THE TIP OF THE SHEATH BROKE OFF IN THE PATIENT AND TRAVELED TO A PULMONARY ARTERY IN THE PATIENT. IT'S IN A PERIPHERY ARTERY AND WAS LEFT IN THE PATIENT. PATIENT IS FINE AND HAS NO ISSUES ON TEST.

  Patient problems: Foreign Body In Patient

  MAUDE report 11227588 ↗
• MalfunctionNov 13, 2020Detachment of Device or Device Component

  TIP (DISTAL 5MM) OF THE SHEATH SEEMED TO TEAR AWAY AND ALMOST DISLODGE DURING THE PROCEDURE. SHEATH STAYED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840513 ↗