AV Sheath Tunneler AVST2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741090530), received between Jul 22, 2019 and Dec 3, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE REPROCESSING INSTRUCTION OUTLINED WITH THE DEVICE WAS NOT IN COMPLIANCE WITH THE GERMAN LAW. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922863 ↗
• MalfunctionMar 1, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE DEVICE IFU FOR CLEANING AND STERILIZATION WAS ALLEGEDLY NOT IN COMPLIANCE WITH THE LOCAL LAWS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395247 ↗
• MalfunctionFeb 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE REPROCESSING INSTRUCTION OUTLINED WITH THE DEVICE WAS NOT IN COMPLIANCE WITH THE GERMAN LAW. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385824 ↗
• MalfunctionJul 22, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVST2000 SURGICAL TUNNELER ALLEGEDLY DISCOVERED THE PACKAGING AND INTERNAL LABELS ALLEGEDLY HAD THE INCORRECT CATALOG NUMBER PRINTED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AND THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8812009 ↗