COVERA AVSM06100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106217), received between Nov 21, 2025 and Sep 11, 2026 — classified as 2 malfunctions.

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

• MalfunctionSep 11, 2026Loss of or Failure to Bond; Break; Positioning Failure

  On (b)(6) 2026, a 53-year-old male patient underwent a stent placement procedure using a Covera Vascular Covered Stent for the treatment of severe stenosis at the juxta-anastomotic region of a left radiocephalic arteriovenous fistula (AVF) via the left radiocephalic access site. During the procedure, it was reported that the stent failed to deploy, as the sheath did not retract when the thumbwheel was rotated. It was further reported that the internal wire did not respond to thumbwheel manipulation. The device was successfully retrieved and different brand of stent used and deployed successfully. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726391 ↗
• MalfunctionNov 21, 2025Break; Positioning Failure; Misfire; Break; Positioning Failure; Misfire

  ON (B)(6) 2025, A PATENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT IN THE ACCESS SITE OF COMMON FEMORAL ARTERY APPROACH FROM THE CONTRALATERAL SIDE. DURING THE PROCEDURE THE COVERA STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615225 ↗