COVERA AVSM10060Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741106392), received between Nov 26, 2018 and Nov 6, 2025 — classified as 16 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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. 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 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 ONE YEAR EIGHT MONTHS AND NINETEEN DAYS POST COVERA STENT PLACEMENT PROCEDURE FOR CEPHALIC VEIN STENOSIS, THE SUBJECT UNDERWENT ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR DECREASED ACCESS BLOOD FLOW AND PULSATILITY. IT WAS FURTHER REPORTED THAT A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED DURING RE-INTERVENTION ON THE TARGET LESION ON CEPHALIC VEIN WITH RESIDUAL STENOSIS OF 15% AND NON-TARGET LESION NOT TREATED AT INDEX PROCEDURE ON THE SUBCLAVIAN VEIN WITH INITIAL STENOSIS OF 29.5% AND FINAL RESIDUAL STENOSIS OF 15%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL, AND NO NEW ACCESS WAS CREATED. THE CURRENT STATUS OF THE SUBJECT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23484118 ↗
• MalfunctionAug 4, 2025Material Deformation; Material Deformation

  ON (B)(6) 2024, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT. DURING THE PROCEDURE, THE STENT ALLEGEDLY COLLAPSED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697033 ↗
• MalfunctionJun 10, 2025Material Deformation; Material Deformation

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT VIA LEFT UPPER ARM ARTERIOVENOUS FISTULA. ON (B)(6) 2024, THE STENT ALLEGEDLY COLLAPSED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173792 ↗
• MalfunctionMar 3, 2025Material Separation; Material Deformation; Activation Failure; Material Separation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FOLDED ON ITSELF. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY CRUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511005 ↗
• MalfunctionMar 3, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FOLDED ON ITSELF. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY CRUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511004 ↗
• MalfunctionDec 12, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT UPPER ARM GRAFT VIA RIGHT ARTERIOVENOUS GRAFT, THE DISTAL END OF THE STENT WAS ALLEGEDLY FOUND TO BE COLLAPSED AFTER DEPLOYMENT. REPORTEDLY, POST DILATION WAS DONE AND THE END OF THE STENT RE-LINED WITH ANOTHER STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911022 ↗
• InjuryNov 20, 2024Adverse 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 MONTHS AND EIGHTEEN DAYS POST ANGIOPLASTY AND STENT PLACEMENT PROCEDURE, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET RIGHT ARM. 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 80% AND FINAL RESIDUAL STENOSIS OF 9%. 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 20731626 ↗
• InjurySep 17, 2024Adverse 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 ONE YEAR, TEN MONTHS AND FOUR DAYS POST INDEX PROCEDURE USING A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT IN THE RIGHT UPPER ARM IN THE CEPHALIC VEIN, THE SUBJECT UNDERWENT AV ACCESS CIRCUIT RE-INTERVENTION ON THE RIGHT ARM. FURTHERMORE, THE RE-INTERVENTION INVOLVED ON THE TARGET LESION AT CEPHALIC VEIN WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 9%. STANDARD PERCUTANEOUS ANGIOPLASTY WAS PERFORMED AND THE RE-INTERVENTION WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 20234919 ↗
• InjuryAug 22, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS NOTED SEVERAL DAYS AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Restenosis

  MAUDE report 20030102 ↗
• InjuryJul 17, 2024Adverse 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 SIX MONTHS POST INDEX PROCEDURE USING A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT IN THE LEFT UPPER ARM IN THE CEPHALIC VEIN, THE SUBJECT HAD AN ADVERSE EVENT OF ARTERIOVENOUS FISTULA ANEURYSM WHICH WAS DEFINITELY RELATED TO AV ACCESS CIRCUIT. IT WAS FURTHER REPORTED THAT TWO YEARS EIGHT MONTHS AND SEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN AV ACCESS CIRCUIT RE-INTERVENTION ON THE LEFT ARM. THE RE-INTERVENTION INVOLVED ON THE TARGET LESION AT CEPHALIC VEIN WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 20%. STANDARD PERCUTANEOUS ANGIOPLASTY AND THROMBECTOMY WAS PERFORMED AND THE RE-INTERVENTION WAS SUCCESSFUL. IT WAS FURTHER REPORTED THAT TWO YEARS TEN MONTHS LATER THE SUBJECT HAD AN ADVERSE EVENT OF SEPTIC SHOCK WITH MULTI-ORGAN DYSFUNCTION SYNDROME AND THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, PROCEDURE AND AV ACCESS CIRCUIT. REPORTEDLY, THE SUBJECT WAS EXPIRED AND THE CAUSE OF DEATH WAS SEPTIC SHOCK WITH MULTI-ORGAN DYSFUNCTION SYNDROME.

  Patient problems: Aneurysm; Restenosis

  MAUDE report 19758921 ↗
• InjuryApr 15, 2024Adverse 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 ONE YEAR, SIX MONTHS, AND EIGHTEEN DAYS POST A STENT GRAFT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE LEFT UPPER ARM, THE SUBJECT DEVELOPED CEPHALIC VEIN RESTENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION DUE TO PULSATILITY AND TWO LARGE ANEURYSM. IT WAS FURTHER REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT PULSATILITY AND TWO LARGE ANEURYSM. TREATMENT REINTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME OF ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 19104516 ↗
• MalfunctionApr 9, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST A STENT GRAFT PLACEMENT, THE STENT WAS ALLEGEDLY NOT IN THE CORRECT LOCATION. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE FLOATING AROUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069484 ↗
• MalfunctionFeb 12, 2024Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC VEIN OUTFLOW VIA THE LEFT UPPER ARM FISTULA, THE WHEEL ALLEGEDLY STOPPED WORKING AFTER BEING ROLLED A TURN OR TWO. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683696 ↗
• MalfunctionMay 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE HEALTHCARE PROFESSIONAL WILL BE RE-STENTING TO AVOID MIGRATION OF FRAGMENTS IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982330 ↗
• InjuryApr 19, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT POST SOMETIME STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT FOREARM AV FISTULA THAT HAD AN OUTFLOW THROUGH UPPER ARM CEPHALIC VEIN, THE STENT GRAFT WAS IDENTIFIED COLLAPSED IN THE CEPHALIC ARCH UNDER ULTRASOUND. THEREFORE, ANGIOPLASTY WAS PERFORMED WITH A 10MM BALLOON, BUT THE STENT GRAFT COLLAPSED ONCE THE BALLOON WAS DEFLATED. ENDOVASCULAR AND OPEN THROMBECTOMY FAILED TO ADEQUATELY CLEAR THE CLOTS OUT OF THE FISTULA. PATIENT STATUS IS UNKNOWN.

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

  MAUDE report 16769654 ↗
• MalfunctionApr 14, 2023Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR STENOSIS DECLOT IN DIALYSIS GRAFT, ONLY THE FIRST COUPLE OF STRUTS WERE ALLEGEDLY DEPLOYED. IT WAS FURTHER REPORTED THAT AT ONE POINT RESISTANCE WAS FELT ON THE WHEEL AND IT WAS NOT DEPLOYING CORRECTLY. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740805 ↗
• MalfunctionMar 10, 2023Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR A 67 YEAR OLD PATIENT WITH A BASILIC SWING POINT STENOSIS IN AN AV FISTULA, THE STENT ALLEGEDLY DID NOT DEPLOY AT ALL. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519721 ↗
• 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 15353524 ↗
• MalfunctionSep 1, 2022Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH LEFT BASILAC VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332949 ↗
• MalfunctionAug 5, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A ACTIVATION FAILURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173062 ↗
• MalfunctionJul 27, 2022Loss of or Failure to Bond; Break; Positioning Failure; Loss of or Failure to Bond; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA DISTAL BASILIC VEIN, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE WHEEL ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109474 ↗
• MalfunctionJul 26, 2022Break; Positioning Failure; Misfire; Break; Positioning Failure; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101230 ↗
• MalfunctionJun 23, 2022Positioning Failure; Fracture; Material Perforation; Misfire; Material Deformation; Positioning Failure; Fracture; Material Perforation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS 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 14785976 ↗
• InjuryApr 25, 2022Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT FOURTEEN DAYS POST STENT PLACEMENT PROCEDURE THROUGH CEPHALIC ARCH, THE STENT WAS ALLEGEDLY BLOCKING OFF THE BASILIC VEIN. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SWELLING IN THE ARM AND SURGICAL INTERVENTION WAS PERFORMED. REPORTEDLY THE STENT HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 14194104 ↗
• InjuryApr 25, 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 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 14191923 ↗