COVERA AVFM08060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741106514), received between Jul 16, 2019 and Nov 17, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Misfire” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Misfire; Material Deformation; Material Twisted/Bent; Misfire; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR STENT FOR THE INDICATION OF STENT PLACEMENT WAS A STENOSIS AT THE BASILIC SWING POINT TO THE AXILLARY VEIN. DURING THE PROCEDURE. IT WAS REPORTED THAT A 8X60MM STENT NARROWED AND THE DISTAL END DID NOT FULLY OPEN. THERE WAS NO ISSUE WITH THE RELEASE OF THE STENT OFF THE SHEATH. EVEN THOUGH THE STENT WAS POST DILATED WITH AN 8MM BALLOON, THE STENT REMAINED COMPRESSED AND DID NOT FULLY OPENED AFTER BALLOON DEFLATION. THE STENT APPEARED TWISTED IN THE VESSEL AND NOT PROPERLY SEATED TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566255 ↗
• MalfunctionSep 6, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT IN THE RIGHT CEPHALIC VEIN VIA RIGHT ARM FISTULA, AFTER STENT DEPLOYMENT THE DELIVERY SYSTEM WAS ALLEGEDLY STUCK AND WOULD NOT EXIT PATIENT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154690 ↗
• MalfunctionApr 6, 2024Break; Positioning Failure; Misfire; Detachment of Device or Device Component; Break; Positioning Failure; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE TO TREAT THE RUPTURED VESSEL VIA LEFT FISTULA, THE PIECE TO ATTACH TO SHAFT TO THE HANDLE WAS ALLEGEDLY NOT ATTACHED. REPORTEDLY, THE DEVICE WAS UNABLE 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 19056570 ↗
• MalfunctionSep 19, 2022Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT UPPER EXTREMITY VENOUS VIA LEFT BRACHIAL ARTERIAL VENOUS FISTULA, THE STENT 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 15444289 ↗
• InjurySep 17, 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 AND EIGHT MONTHS 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: Stenosis

  MAUDE report 12486626 ↗
• MalfunctionJul 15, 2020Misfire; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVFM08060 VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED A MISFIRE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT CONSEQUENCE. THE PATIENT IS MALE, (B)(6) YEARS OLD, AND WEIGHS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277227 ↗
• InjuryOct 21, 2019Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF THE CEPHALIC ARC VIA RIGHT ARM FISTULA ACCESS, THE COVERED STENT DEPLOYED PROPERLY; HOWEVER, UPON REMOVAL, THE TIP OF THE DELIVERY SYSTEM WAS CAUGHT AND A BREAK ALLEGEDLY OCCURRED SPANNING FROM THE TIP TO THE HANDLE. IT WAS FURTHER REPORTED THAT DUE TO THE BREAK, PART OF THE DELIVERY SYSTEM DETACHED AND A SNARE WAS REQUIRED TO RETRIEVE IT USING A NEW ACCESS SITE, THE RIGHT FEMORAL. REPORTEDLY, THE PATIENT UNDERWENT BLOOD LOSS AND REQUIRED AN ADDITIONAL PROCEDURE THE FOLLOWING DAY TO PLACE A TEMPORARY DIALYSIS CATHETER. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Blood Loss

  MAUDE report 9215754 ↗
• InjuryOct 10, 2019Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A COVERED STENT PLACEMENT PROCEDURE WITHIN THE CEPHALIC ARCH, THE PATIENT ALLEGEDLY EXPERIENCED THROMBOSIS AFTER POST DILATING THE COVERED STENT. IT WAS FURTHER REPORTED THAT THE CLOT WAS REMOVED FROM WITHIN THE STENT. THE PATIENT WAS REPORTEDLY STABLE POST CLOT REMOVAL.

  Patient problems: Thrombosis

  MAUDE report 9175423 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 1-YEAR 1-MONTH POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. STANDARD PTA AND THROMBECTOMY WERE USED TO TREAT THE LESION WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED APPROXIMATELY 1-YEAR 11-MONTH POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. STANDARD PTA AND THROMBECTOMY WERE USED TO TREAT THE LESION WITH SUCCESSFUL RESULT. THE STUDY WAS COMPLETED ON 10-DEC-2018.

  Patient problems: Stenosis

  MAUDE report 8794460 ↗