COVERA AVFM09060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741106552), received between Jul 11, 2019 and Sep 2, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT ALLEGEDLY CAME BACK TANGLE IN MIDDLE, LIKE A CANDY WRAPPER TWISTED AT THE END. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 22932203 ↗
• MalfunctionDec 23, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY CLAMPED DOWN WHEN DEPLOYED. IT WAS FURTHER REPORTED THAT THE POST DILATION WAS DONE, THE STENT GRAFT ALLEGEDLY WOULD CLAMP DOWN. THE PROCEDURE WAS COMPLETED USING LINING THE STENT WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20998251 ↗
• 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 MONTH AND FOURTEEN DAYS POST A STENT GRAFT PLACEMENT IN THE BASILIC VEIN AT BASILIC VEIN OUTFLOW VIA THE RIGHT UPPER ARM, THE SUBJECT HAD TARGET LESION RESTENOSIS. IT WAS FURTHER REPORTED THAT FOUR MONTHS AND EIGHTEEN DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT HAD TARGET LESION RESTENOSIS. IT WAS ALSO REPORTED THAT NINE MONTHS AND SIXTEEN DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT HAD TARGET LESION RESTENOSIS. FURTHERMORE, ONE YEAR, THREE MONTHS, AND TWENTY DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT HAD TARGET LESION RESTENOSIS. MOREOVER, TWO YEARS, ONE MONTH, AND THREE DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT HAD TARGET LESION RESTENOSIS. IN ADDITION, TWO YEARS, TEN MONTHS, AND NINETEEN DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT HAD TARGET LESION RESTENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT THE TARGET LESION RESTENOSIS. 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 19104515 ↗
• MalfunctionAug 10, 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 LEFT ARM, THE STENT WAS ALLEGEDLY UNABLE TO DEPLOY. IT WAS FURTHER REPORTED THAT THE WHEEL WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196852 ↗
• InjuryJun 1, 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 FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT HAD AN ADVERSE EVENT OF BLEEDING. IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS RELATED TO THE STUDY DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14562490 ↗
• InjuryDec 16, 2021Free or Unrestricted Flow; Adverse Event Without Identified Device or Use Problem; Free or Unrestricted Flow; 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, DECREASED ACCESS BLOOD FLOW WAS NOTED AS AN ADVERSE EVENT POSSIBLY RELATED TO STUDY DEVICE, ARTERIOVENOUS (AV) ACCESS CIRCUIT AND NOT RELATED TO THE PROCEDURE. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 13015720 ↗
• MalfunctionJul 20, 2021Fracture; Material Deformation; Activation Failure; Fracture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195176 ↗
• 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 ONE MONTH AND TWELVE DAYS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED. A STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883103 ↗
• MalfunctionJul 17, 2019Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE EVENT INDICATED THAT MODEL AVFM09060 VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED AFTER DEPLOYMENT IN THE LEFT FEMORAL GRAFT AT THE VENOUS ANASTOMOSIS VIA VEIN ACCESS, THE DELIVERY SYSTEM REPORTEDLY REQUIRED EXCESSIVE FORCE TO RETRACT FROM THE DISTAL END OF THE STENT GRAFT AND CAUSED THE STENT GRAFT TO BEND INWARD. IT WAS FURTHER REPORTED THAT THE STENT GRAFT UNDERWENT POST-DILATATION AND WAS NO LONGER DEFORMED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE FEMALE PATIENT, WEIGHING (B)(6) LBS, AGE WAS NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798716 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 4-MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS AND PATIENT EXPERIENCED ARM AND HAND SWELLING WAS IDENTIFIED. STANDARD PTA WAS PERFORMED WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED THAT APPROXIMATELY ONE-YEAR 4-MONTH POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. STANDARD PTA WAS PERFORMED WITH SUCCESSFUL RESULT. THE STUDY WAS COMPLETED ON 04-FEB-2019.

  Patient problems: Stenosis; Swelling

  MAUDE report 8795514 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 1 YEAR 10-MONTH POST INDEX PROCEDURE, STENOSIS WAS IDENTIFIED AT THE TARGET LESION. PTA BALLOON WAS USED TO TREAT THE LESION WITH RESULT OF 7% RESIDUAL STENOSIS POST PROCEDURE. THE OUTCOME OF THE EVENT WAS RESOLVED AND RECOVERED.

  Patient problems: Stenosis

  MAUDE report 8794654 ↗
• MalfunctionJul 11, 2019Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Material Deformation; Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVFM09060 VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED DIFFICULTY TO DEPLOY, DIFFICULTY TO REMOVE, ENTRAPMENT, AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A FEMALE WHO WEIGHED (B)(6) LBS. THE PATIENT¿S AGE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783336 ↗