COVERA AVFM08080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741106521), received between Jul 16, 2019 and Jun 26, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfire” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE PROXIMAL BASILIC VEIN VIA LEFT FEMORAL ARTERY, WHEN ATTEMPTED TO DEPLOY THE STENT ALLEGEDLY WOULD ONLY DEPLOY HALFWAY. IT WAS FURTHER REPORTED THAT THE PARTIALLY DEPLOYED STENT WAS REMOVED AND RE-CANNULATED LEFT FEMORAL ARTERY GRAFT ON THE VENOUS ASPECT IN ORDER TO REMOVE THE CURVE OF THE GRAFT. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612775 ↗
• MalfunctionMar 28, 2023Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625996 ↗
• InjuryOct 20, 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 MONTHS AND EIGHT DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 70% OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), BARE METAL STENT AND THROMBECTOMY/THROMBOLYSIS WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 12666345 ↗
• InjuryApr 20, 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, APPROXIMATELY ONE MONTH AND SEVEN WEEKS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED THROMBOSED LEFT UPPER ARM AVF AND AV ACCESS CIRCUIT RE-INTERVENTION WAS PERFORMED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11692156 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 5-MONTH POST INDEX (B)(6) 2017) PROCEDURE DECREASED ACCESS BLOOD FLOW WAS IDENTIFIED. A STANDARD PTA WAS PERFORMED TO TREAT THE STENOSIS IN THE TARGET LESION. IT WAS FURTHER REPORTED APPROXIMATELY 8-MONTH POST INDEX (B)(6) 2017) PROCEDURE DECREASED ACCESS BLOOD FLOW WITH 80% STENOSIS IN THE TARGET LESION. STANDARD PTA WAS USED TO TREAT THE LESION. IT WAS REPORTED APPROXIMATELY 8-MONTH POST INDEX (B)(6) 2017) PROCEDURE SWELLING ARM OR HAND ALONG WITH 80% STENOSIS IN THE TARGET LESION. STANDARD PTA WAS USED TO TREAT THE LESION. IT WAS FURTHER REPORTED APPROXIMATELY 11-MONTH POST INDEX (B)(6) 2017) PROCEDURE DECREASED ACCESS BLOOD FLOW WITH 80% STENOSIS IN THE TARGET LESION. STANDARD PTA WAS USED TO TREAT THE LESION.

  Patient problems: Stenosis

  MAUDE report 8796022 ↗