COVERA AVFM07060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106477), received between Feb 24, 2022 and Jun 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionJun 27, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  ON (B)(6) 2025, A PATIENT UNDERWENT A PROCEDURE USING THE COVERA VASCULAR COVERED STENT. PRIOR TO THE STENT PLACEMENT PROCEDURE, THE PRODUCT HAD WAS ALLEGEDLY DAMAGED UPON ARRIVAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343168 ↗
• MalfunctionFeb 24, 2022Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CEPHALIC VEIN, THE STENT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591633 ↗