COVERA AVFM09080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106569), received between Nov 7, 2024 and Jan 8, 2026 — classified as 2 malfunctions.

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

• MalfunctionJan 8, 2026Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A COVERA STENT. IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, PART OF THE STENT ALLEGEDLY STUCK TO THE PAD AND WOULD NOT FULLY OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000715 ↗
• MalfunctionNov 7, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT UPPER ARM FISTULA, THE STENT SUCCESSFULLY UNLOCKED AND BEGAN TURNING THEN ALLEGEDLY STOPPED. IT WAS FURTHER REPORTED THAT ALLEGEDLY THERE WAS A POP SOUND HEARD AND THE PHYSICIAN UNDERSTOOD THE STRING PROBABLY SNAPPED. REPORTEDLY, THE STENT ALLEGEDLY DID NOT DEPLOY AT ALL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627164 ↗