COVERA AVFM10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741106606), received between Mar 4, 2020 and Aug 26, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  A PATIENT UNDERWENT A STENT PLACEMENT SURGERY PROCEDURE USING COVERA VASCULAR COVERED STENT ABOUT 1 MONTH AGO. DURING FOLLOW-UP IT WAS FOUND THAT THE POST DECLOT AND ACCESS WAS HYPER PULSATILE AND INSIDE THE STENT IS ANOTHER CRUSHED STENT THAT IS CRUSHED. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 22893129 ↗
• InjuryJun 11, 2025Material Deformation; Material Deformation

  ON (B)(6) 2024, A PATIENT UNDERWENT THE STENT GRAFT PLACEMENT PROCEDURE. IT WAS REPORTED THAT POST A STENT GRAFT PLACEMENT, STENT ALLEGEDLY COLLAPSED. THE PATIENT DEVELOPED HEMATOMA AROUND THE COLLAPSED STENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 22181972 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY THREE YEARS AND ELEVEN DAYS POST ANGIOPLASTY AND STENT PLACEMENT PROCEDURE, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM CEPHALIC VEIN STENOSIS. IT WAS FURTHER REPORTED THAT A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED DURING RE-INTERVENTION ON THE TARGET LESION CEPHALIC VEIN WITH INITIAL STENOSIS OF 70% AND FINAL RESIDUAL STENOSIS OF 0%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS WAS CREATED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 22000047 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT ONE YEAR SEVEN MONTHS AND TWENTY-TWO DAYS POST INDEX PROCEDURE, THE TARGET LESION AT CEPHALIC VEIN ARCH HAD A MAXIMUM INITIAL LESION STENOSIS OF EIGHTY PERCENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF ZERO PERCENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 16634288 ↗
• InjuryFeb 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT SOMETIME 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 16416118 ↗
• InjuryApr 24, 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 FIVE MONTHS AND FOUR DAYS 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 PATIENT IS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 14191425 ↗
• InjuryFeb 15, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE YEAR AND ONE MONTH 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 13531556 ↗
• 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 SIX 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 PATIENT WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12391810 ↗
• InjuryDec 8, 2020Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT THE SAME DAY OF IMPLANTATION OF A COVERED STENT SPASM OF THE OUTFLOW VEIN OCCURRED POST IMPLANTATION OF THE STENT AND WAS TREATED WITH PTA THE SAME DAY. THE PATIENT WAS DISCHARGED THE SAME DAY. THE STENT HAS BEEN PLACED TO TREAT A 90% STENOSIS IN THE CEPHALIC VEIN ARCH OF AN AV ACCESS CIRCUIT THAT WAS CREATED 10 MONTHS AGO. DURING A 6 MONTH FOLLOW UP A TARGET LESION RE-STENOSIS OF 62% WAS FOUND. STANDARD PTA WAS USED FOR TREATMENT AND THE RE-INTERVENTION PROCEDURE WAS SUCCESSFUL. RESIDUAL STENOSIS OF 10% WAS REPORTED. DURING A 12 MONTH FOLLOW UP BY PHONE NO CANNULATION ZONE ABNORMALITIES AND NO CLINICAL INDICATORS OF ACCESS DYSFUNCTION WERE REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Cramp(s) /Muscle Spasm(s); Device Overstimulation of Tissue; Restenosis

  MAUDE report 10964179 ↗
• InjuryMar 4, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 9-MONTHS POST INDEX PROCEDURE, 60.3% TARGET LESION STENOSIS AND STANDARD PTA WAS PERFORMED TO TREAT LESION. IT WAS FURTHER REPORTED APPROXIMATELY 2 YEARS POST INDEX PROCEDURE 70% STENOSIS WAS IDENTIFIED AND STANDARD PTA WAS PERFORMED TO TREAT LESION. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 9789021 ↗