COVERA AVSM08100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741106316), received between Oct 22, 2020 and Aug 25, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse 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 THREE DAYS POST INDEX PROCEDURE USING A COVERA VASCULAR COVERED STENT IN THE RIGHT UPPER ARM ON THE CEPHALIC VEIN TARGET LESION, THE SUBJECT HAD A RE-INTERVENTION PERFORMED BY USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, ON THE TARGET LESION WITHIN THE ACCESS CIRCUIT WITH INITIAL STENOSIS OF 70% AND FINAL RESIDUAL STENOSIS OF 0%, AND ON A NEW LESION WITHIN THE ACCESS CIRCUIT WITH INITIAL STENOSIS OF 60% AND FINAL RESIDUAL STENOSIS OF 0%. FURTHERMORE, THE RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS WAS CREATED, AND THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 22881932 ↗
• MalfunctionNov 16, 2023Component Missing; Missing Information; Component Missing; Missing Information

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY EMPTY. IT WAS FURTHER REPORTED THAT THE PACKAGE ALLEGEDLY HAD NO LABEL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155074 ↗
• MalfunctionOct 25, 2022Positioning Failure; Improper or Incorrect Procedure or Method; Malposition of Device; Positioning Failure; Improper or Incorrect Procedure or Method; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665573 ↗
• 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 TWO MONTHS AND SEVENTEEN DAYS POST INDEX PROCEDURE, STEAL SYNDROME WAS OBSERVED. IT WAS FURTHER REPORTED THAT PATIENT HAD STENOSIS IN THE TARGET LESION AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Ischemia; Restenosis; Unspecified Tissue Injury

  MAUDE report 14192428 ↗
• MalfunctionOct 22, 2020Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AVSM08100 VASCULAR STENT ALLEGEDLY EXPERIENCED DIFFICULT, OR DELAYED POSITIONING AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A MALE PATIENT, HOWEVER, AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722807 ↗