COVERA AVSM10040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741106385), received between Aug 30, 2021 and Nov 6, 2025 — classified as 12 injuries, 3 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT. REPORTEDLY, THE STENT GOT FRACTURED. THEY HAVE HAD PREVIOUS ISSUES WITH COVERA. THERE ARE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484117 ↗
• MalfunctionJul 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT'S FISTULA WAS FOUND CLOTTED IN LESS THAN ONE MONTH AFTER PLACEMENT OF THE STENT. IT WAS IDENTIFIED THAT THE PERIPHERAL END OF STENT WAS COLLAPSED AND IT WAS EXTREMELY DIFFICULT TO PASS THE WIRE INTO CENTRAL VEINS. ANGIOPLASTY WAS PERFORMED OF THE COLLAPSED STENT USING A 10MM ANGIOPLASTY BALLOON TO STRAIGHTENED THE STENT. ANOTHER BRAND STENT WAS PLACED WITH GOOD RESULT ON BOTH ANGIOGRAM AND PHYSICAL EXAMINATION. THE PATIENT¿S FISTULA IS WORKING WELL DURING DIALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456872 ↗
• InjuryApr 30, 2025Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  ON (B)(6) 2025, A 59-YEAR-OLD MALE PATIENT UNDERWENT HAD A LEFT FOREARM AV FISTULA ACCESS. ON (B)(6) 2025 THE PATIENT ALLEGEDLY COMPLAINTS ABOUT CLOTTED ACCESS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21932681 ↗
• InjuryApr 30, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 59-YEAR-OLD MALE PATIENT UNDERWENT HAD A LEFT FOREARM AV FISTULA ACCESS, WITH SLIGHTLY SWOLLEN FOREARM. IT WAS REPORTED THAT AFTER AN INTERVENTION WAS PERFORMED AND A 10X4 COVERA WAS USED THE PATIENT COMPLAINT ABOUT MORE SWELLING AND PAIN. REPORTEDLY THE STENT HAD ALLEGEDLY KINKED AND DEFORMED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21932466 ↗
• InjuryAug 26, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT FOREARM, WHILE PULLING THE CATHETER AFTER DEPLOYMENT, IT ALLEGEDLY GOT STUCK IN STENT AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM WAS ALLEGEDLY CUT OUTSIDE THE PATIENT. REPORTEDLY THE PATIENT WAS REFERRED TO VASCULAR SURGEON. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20062007 ↗
• InjuryOct 31, 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 SOMETIME POST INDEX PROCEDURE, USING A STENT GRAFT, SUBJECT DEVELOPED EIGHTY PERCENT OF STENOSIS AND WAS SUCCESSFULLY TREATED WITH COVERA VASCULAR STRAIGHT STENT GRAFT. APPROXIMATELY ONE YEAR TWO MONTHS AND 14 DAYS POST INDEX PROCEDURE, EVENT REQUIRED REINTERVENTION. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO TREAT THE TARGET LESION AND THE REINTERVENTION WAS SUCCESSFUL. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 15697872 ↗
• InjuryOct 10, 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 THREE MONTHS AND ONE DAY POST INDEX PROCEDURE, THE SUBJECT DEVELOPED SEVENTY PERCENT OF STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. AFTER FOUR MONTHS AND SEVENTEEN DAYS POST STUDY DEVICE IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH ANEURYSM AND STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR TREATMENT. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 15568632 ↗
• InjuryApr 12, 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 2 MONTHS AND 30 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 SUBJECT IS NOT PROVIDED.

  Patient problems: Fistula; Stenosis

  MAUDE report 14081397 ↗
• InjuryFeb 23, 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 THREE MONTHS AND FOURTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED SEVENTY PERCENT OF STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. AFTER EIGHT MONTHS AND TWENTY NINE DAYS POST STUDY DEVICE IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH ANEURYSM AND STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR TREATMENT. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 13585067 ↗
• InjuryFeb 4, 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 TWELVE MONTHS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED. A STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 13450178 ↗
• MalfunctionOct 21, 2021Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN THROUGH THE ANEURYSMAL FISTULA, ONLY THE TIP OF THE STENT WAS ALLEGEDLY FOUND TO BE DEPLOYED. THE DEVICE WAS REMOVED OFF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674059 ↗
• InjuryOct 19, 2021Obstruction 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 SIX MONTHS AND FIFTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 70% OF TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 12653252 ↗
• InjuryOct 19, 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 AND ELEVEN DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 50% 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 12653247 ↗
• InjurySep 16, 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 SEVEN DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 30% 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 12479009 ↗
• 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 FIVE MONTHS AND ONE DAY POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 80% OF TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis; Stenosis

  MAUDE report 12382693 ↗