COVERA AVFM09040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106545), received between Sep 15, 2021 and Oct 25, 2022 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Dec 22, 2022Open, Classified

   An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

   Z-1108-2023 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Adverse 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 APPROXIMATELY SIX MONTHS AND FIVE DAYS POST STENT PLACEMENT PROCEDURE, THE PATIENT HAD AN ADVERSE EVENT OF STEAL SYNDROME. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT SURGICAL PROCEDURE FOR STEAL SYNDROME. THE ADVERSE EVENT RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED, AV ACCESS CIRCUIT WAS DEFINITELY RELATED AND NOT RELATED TO THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Ischemia

  MAUDE report 15665404 ↗
• InjurySep 15, 2021Adverse 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 APPROXIMATELY TWO YEARS TWO MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 70% OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 12472911 ↗