COVERA AVFM10040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741106583), received between Aug 28, 2019 and Sep 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 60% 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 12472914 ↗
• InjuryAug 31, 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 TEN MONTHS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE SUBJECT WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12391723 ↗
• InjuryAug 28, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 2-YEAR POST INDEX PROCEDURE, PARTIAL THROMBOSIS AND OCCLUSION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. NEW INFORMATION: IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THE PARTIAL EXPERIENCED BUMPS ON FISTULA AND CEPHALIC VEIN WAS OCCLUDED. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT.

  Patient problems: Occlusion; Stenosis; Thrombosis

  MAUDE report 8941183 ↗