COVERA AVFM10060Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741106590), received between Apr 8, 2020 and Oct 9, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2025Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT. DURING THE PROCEDURE COVERA STENT WAS DEPLOYED IN A FISTULA. IT WAS REPORTED THAT, THE STENT SEEMED TO FULLY DEPLOY BUT ALLEGEDLY FAILED TO RELEASE FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED FORCEFULLY FROM THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 23252709 ↗
• InjuryAug 14, 2025Material Deformation; Material Deformation

  A PATIENT UNDERWENT A COVERA STENT PLACEMENT SURGERY ONE MONTH AGO. DURING FOLLOW-UP IT WAS FOUND THAT THE POST DECLOT AND ACCESS WAS HYPER PULSATILE AND INSIDE THE STENT IS CRUSHED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 22802298 ↗
• InjuryAug 14, 2025Material Deformation; Material Deformation

  A PATIENT UNDERWENT A COVERA STENT PLACEMENT, INSIDE THE STENT IS ANOTHER CRUSHED STENT THAT IS CRUSHED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 22802296 ↗
• MalfunctionJul 31, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE BOX OF THE DEVICE HAD ALLEGEDLY OPENED ON ONE END AND TAPED SHUT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19879474 ↗
• InjuryFeb 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT FIVE DAYS POST STENT PLACEMENT, THE STENT ALLEGEDLY GOT BUCKLED. IT WAS FURTHER REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED BY PLACING ADDITIONAL STENTS FOR THE REPORTED STENT BUCKLING. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416073 ↗
• MalfunctionSep 3, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD PARTIAL DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353525 ↗
• InjurySep 30, 2021Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT A FEW DAYS POST STENT PLACEMENT PROCEDURE IN THE LUE AV FISTULA, BLOOD FLOW WAS ALLEGEDLY NOTED TO BE OBSTRUCTED. IT WAS FURTHER REPORTED THAT THE PATIENT'S UPPER ARM WAS RED, SWOLLEN AND WAS PAINFUL. UPON EXAMINATION, THE STENT WAS FOUND TO BE COLLAPSED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12555449 ↗
• InjurySep 1, 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 FOUR 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 12405450 ↗
• 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 A STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE SUBJECT WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12390193 ↗
• InjuryAug 30, 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 ONE YEAR 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 12382004 ↗
• InjuryMay 26, 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 THREE MONTHS SIX DAYS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED. STANDARD PTA AND BARE METAL WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883124 ↗
• MalfunctionNov 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A COVERED STENT PLACEMENT PROCEDURE IN A PRE-DILATED VESSEL TO BRIDGE TWO STENT GRAFTS, THE COVERED STENT COMPRESSED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN DEPLOYED ANOTHER COVERED STENT TO FILL THE GAP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10815740 ↗
• InjuryApr 20, 2020Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SEVERAL DAYS POST COVERED STENT PLACEMENT THE NON FLARED END OF THE STENT WAS FOUND ALLEGEDLY FOLDED OCCLUDING THE VESSEL. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Occlusion; Stenosis

  MAUDE report 9979806 ↗
• InjuryApr 8, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, STENOSIS IN THE TARGET LESION WAS IDENTIFIED AND STANDARD PTA AND THROMBECTOMY WERE PERFORMED. APPROXIMATELY FIVE MONTHS AND ONE YEAR SIX MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED AND RE-INTERVENTION WAS PERFORMED, INCLUDING PTA. APPROXIMATELY TWO YEARS SEVEN MONTHS POST INDEX PROCEDURE, AN AV FISTULA ANEURYSM WAS IDENTIFIED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE AV FISTULA WAS RESECTED AND AN AV GRAFT WAS PLACED. THE PATIENT COMPLETED THE STUDY.

  Patient problems: Numbness; Pain; Stenosis

  MAUDE report 9936055 ↗