COVERA AVSM06060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741106194), received between Apr 16, 2019 and Aug 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Material Separation; Failure to Advance; Device-Device Incompatibility; Difficult to Advance; Material Separation; Failure to Advance; Device-Device Incompatibility; Difficult to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING AN COVERA STENT FOR A LOWER LIMB ANGIOPLASTY. DURING THE PROCEDURE, WHEN THE STENT WAS INTENDED FOR DEPLOYMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE STENT COULD NOT BE ADVANCED TO THE LESION IN THE SFA DUE TO DIFFICULTY CROSSING THE AORTIC BIFURCATION. WITH ADDITIONAL FORCE, THE OUTER COVER OF THE DEVICE SLIPPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892351 ↗
• MalfunctionJan 5, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN DISTAL CEPHALIC VEIN, THE STENT WAS ALLEGEDLY UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173622 ↗
• MalfunctionApr 16, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY MOVED 2MM RESULTING IN ANOTHER STENT GRAFT TO BE PLACED TO COVER THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8519700 ↗