COVERA AVFM08040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741106507), received between Jul 16, 2019 and Jul 9, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Migration or Expulsion of Device

  On b)(6) 2026, a patient underwent a stent placement procedure using a Covera Vascular Covered Stent. During the procedure, while the delivery system was being withdrawn following stent deployment, the stent migrated distally by approximately 6 cm. To secure the migrated stent, an additional stent was deployed. It was further reported that the patient has a functioning shunt and is being closely monitored to assess continued access patency and stent stability. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762528 ↗
• InjuryDec 9, 2023Adverse 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 ONE YEAR AND TWO MONTHS POST STENT PLACEMENT, THE SUBJECT EXPERIENCED TARGET LESION RE-STENOSIS AND AN ARTERIOVENOUS (AV) ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED. IT WAS FURTHER REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO SUCCESSFULLY TREAT THE TARGET LESION RE-STENOSIS AND THE RE-INTERVENTION WAS SUCCESSFUL. FURTHERMORE, ONE YEAR, TWO MONTHS AND TWENTY-FIVE DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF SEPSIS FOLLOWING UNRELATED GASTROINTESTINAL SURGERY. HOWEVER, THE ADVERSE EVENT WAS NOT RELATED TO THE INDEX PROCEDURE, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE ARTERIOVENOUS (AV) ACCESS CIRCUIT. REPORTEDLY, THE SUBJECT EXPIRED IN THE PALLIATIVE CARE AND THE PRIMARY CAUSE OF DEATH WAS INFECTION FOLLOWING CHOLECYSTECTOMY. HOWEVER, THE RELATIONSHIP OF THE DEATH WAS NOT RELATED TO THE STUDY DEVICE, NOT RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE ARTERIOVENOUS (AV) ACCESS CIRCUIT.

  Patient problems: Restenosis

  MAUDE report 18298102 ↗
• InjuryJul 18, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY EIGHT MONTHS POST INDEX PROCEDURE, 50% STENOSIS LESION WAS IDENTIFIED. IT WAS FURTHER REPORTED RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED DURING 24-MONTH FOLLOW-UP, STENOSIS WAS IDENTIFIED, AND STANDARD PTA WAS USED TO TREAT THE LESION.

  Patient problems: Stenosis

  MAUDE report 8805394 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 1 YEAR 7-MONTH POST INDEX PROCEDURE, 80% STENOSIS WAS IDENTIFIED AT THE TARGET LESION. PTA BALLOON WAS USED TO TREAT THE LESION WITH RESULT OF 10% RESIDUAL STENOSIS POST PROCEDURE. THE OUTCOME OF THE EVENT WAS RESOLVED AND RECOVERED.

  Patient problems: Stenosis

  MAUDE report 8794462 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY EIGHT MONTHS POST INDEX PROCEDURE, 50% STENOSIS LESION WAS IDENTIFIED. IT WAS FURTHER REPORTED RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED DURING 24-MONTH FOLLOW-UP, STENOSIS WAS IDENTIFIED, AND STANDARD PTA WAS USED TO TREAT THE LESION.

  Patient problems: Stenosis

  MAUDE report 8794458 ↗